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Exercise counselling to promote exercise behaviour change in individuals with prostate cancer Weller, Sarah Krystal 2019

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EXERCISE COUNSELLING TO PROMOTE EXERCISE BEHAVIOUR CHANGE IN INDIVIDUALS WITH PROSTATE CANCER  by  Sarah Krystal Weller  BAppSci(HMS), The University of Queensland, 2006  A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF  MASTER OF SCIENCE in THE FACULTY OF GRADUATE AND POSTDOCTORAL STUDIES (Rehabilitation Sciences)  THE UNIVERSITY OF BRITISH COLUMBIA (Vancouver)  October 2019  © Sarah Krystal Weller, 2019  ii  The following individuals certify that they have read, and recommend to the Faculty of Graduate and Postdoctoral Studies for acceptance, a thesis/dissertation entitled:  Exercise counselling to promote exercise behaviour change in individuals with prostate cancer  submitted by Sarah Krystal Weller in partial fulfillment of the requirements for the degree of Master of Science in Rehabilitation Sciences  Examining Committee: Dr. Kristin Campbell, Physical Therapy Supervisor  Dr. Guy Faulkner, Kinesiology Supervisory Committee Member  Dr. Celestia Higano, University of Washington Supervisory Committee Member Dr. Linda Li, Physical Therapy Additional Examiner   iii  Abstract  Exercise has been shown to be an effective strategy to enhance survivorship and improve quality of life in individuals with prostate cancer. However, the majority of men with prostate cancer do not meet the exercise guidelines for cancer survivors that recommend achieving a minimum of 150-minutes of moderate-to-vigorous aerobic exercise and two resistance exercise sessions weekly. To assist in the adoption and maintenance of exercise behaviours, the Prostate Cancer Supportive Care (PCSC) program implemented an exercise clinic that included group education and individualized exercise counselling delivered by an exercise physiologist. The primary aim of this dissertation was to evaluate the feasibility of the delivery of the exercise clinic and to understand the preliminary effect of this clinic at changing exercise behaviours over a 3-month period.  A retrospective chart review was performed on data collected from attendees of the PCSC Program Exercise Clinic version 2.0 protocol from June 11 2018 to April 10 2019 from four appointment sessions: Education session, exercise clinic session 1 (first in-person exercise clinic session), exercise clinic session 2 (telephone follow-up session) and exercise clinic session 3 (3-month in-person follow-up session). Feasibility was defined a priori and measured by attendance, attrition, session timing, intervention delivery fidelity and intervention component fidelity. Self-reported aerobic and resistance exercise levels were evaluated at each session. The results show that this study exceeded feasibility targets for attendance, attrition, intervention fidelity and in-person session timing. There was intervention component fidelity in 38 of 39 components. Aerobic exercise levels at 3-months had increased by 83±198 minutes per week of moderate-to-vigorous aerobic exercise with a moderate effect (ES 0.54, 95% CI 0.3-0.5) and iv  resistance exercise increased by 2.0±3.1 sessions per week with a large effect (ES 0.77, 95% CI 0.3-1.3).  Overall, this intervention was feasible to deliver to individuals with prostate cancer in a real-world clinical setting by exercise physiologists. The exercise counselling intervention elicited a moderate effect, showing improvements in aerobic and resistance exercise levels across 3-months. Future work should explore if this behaviour change can be sustained longer-term.    v  Lay Summary  Exercise has been shown to be safe and beneficial for men with prostate cancer and can help to overcome treatment side effects and improve quality of life. However, most men with prostate cancer do not meet exercise recommendations that encourage 150 minutes of moderate-to-vigorous aerobic exercise and two resistance exercise sessions weekly. To support prostate cancer survivors to become more active, an exercise counselling clinic was introduced at the Prostate Cancer Supportive Care (PCSC) program. This study evaluates the delivery and preliminary effect of the PCSC program’s exercise counselling clinic. Overall, high attendance and low drop-out was seen and the exercise counselling clinic improved aerobic and resistance exercise levels over a 3-month period. These results show that exercise counselling is one strategy that could assist prostate cancer survivors in becoming more active. More research is needed to understand if these changes can be sustained over longer periods. vi  Preface  This thesis contains the work of a research study conducted by the candidate, Sarah Krystal Weller, under the supervision of Dr. Kristin L. Campbell, with guidance from Dr. Guy Faulkner and Dr. Celestia Higano. Study design, data cleaning and analysis, and writing of the manuscript were primarily the work of the candidate. Data collection was performed by staff of the PCSC Program (the program delivering the intervention being evaluated). Sections of this thesis will be submitted for publication as a manuscript in a peer-reviewed journal. Ethical approval for this research was provided by the UBC Clinical Research Ethics Board (H19-01740). vii  Table of Contents  Abstract ......................................................................................................................................... iii Lay Summary .................................................................................................................................v Preface ........................................................................................................................................... vi Table of Contents ........................................................................................................................ vii List of Tables ................................................................................................................................ xi List of Figures .............................................................................................................................. xii List of Symbols ........................................................................................................................... xiii List of Abbreviations ................................................................................................................. xiv Acknowledgements .................................................................................................................... xvi Chapter 1: Introduction ................................................................................................................1 Chapter 2: Background .................................................................................................................5 2.1 Prostate cancer treatments ..................................................................................................... 5 2.2 Side effects of treatment ....................................................................................................... 6 2.3 Exercise management of treatment side effects .................................................................... 8 2.4 Impact of exercise on survival and prostate cancer progression ......................................... 11 2.5 Ability of individuals with Prostate cancer to meet exercise recommendations ................ 13 2.6 Exercise adoption in men with prostate cancer ................................................................... 16 2.7 Long-term adherence to exercise in men with prostate cancer ........................................... 21 2.8 Outline of Behaviour Change Techniques (BCTs) for interventions with cancer survivors................................................................................................................................................... 23 2.9 Implementation of exercise for prostate cancer survivors into clinical settings ................. 27 viii  2.10 Effectiveness of exercise delivery mode in men with prostate cancer ............................. 29 2.10.1 Home and distance-based exercise ....................................................................... 30 2.10.2 Potential of exercise counselling to increase exercise levels in men with prostate cancer ............................................................................................................................... 33 2.11 PCSC Program Exercise ................................................................................................... 36 2.12 Summary of literature ....................................................................................................... 38 2.13 Purpose .............................................................................................................................. 39 2.14 Objectives & Hypotheses .................................................................................................. 39 Chapter 3: Methods .....................................................................................................................42 3.1 Study design ........................................................................................................................ 42 3.2 Study Participants ............................................................................................................... 42 3.3 Exercise Clinic version 2.0 protocol ................................................................................... 43 3.3.1 Education session .................................................................................................. 43 3.3.2 Exercise Clinic Sessions ....................................................................................... 44 3.4 Outcome measures .............................................................................................................. 49 3.4.1 Primary outcome measures: Feasibility ................................................................ 49 3.4.2 Secondary outcome measures: Change in self-reported exercise behaviours ...... 52 3.4.3 Tertiary Measures: Task self-efficacy and exercise levels ................................... 53 3.4.4 Exploratory Measures ........................................................................................... 54 3.5 Ethics and Informed Consent .............................................................................................. 57 3.6 Statistical Analysis .............................................................................................................. 57 3.6.1 Sample size ........................................................................................................... 57 3.6.2 Analysis................................................................................................................. 57 ix  3.7 Tables and Figures .............................................................................................................. 60 Chapter 4: Results ........................................................................................................................64 4.1 Participants .......................................................................................................................... 64 4.2 Attendance .......................................................................................................................... 65 4.3 Attrition ............................................................................................................................... 66 4.4 Session Timing ................................................................................................................... 66 4.5 Fidelity of Intervention ....................................................................................................... 67 4.5.1 Intervention delivery fidelity ................................................................................ 67 4.5.2 Intervention component fidelity ............................................................................ 68 4.6 Change in self-reported exercise behaviours ...................................................................... 68 4.6.1 Aerobic exercise .................................................................................................... 68 4.6.2 Resistance exercise ............................................................................................... 69 4.7 Comparison of exercise behaviours: clinic 2.0 and 1.0 ...................................................... 69 4.7.1 Moderate-to-vigorous aerobic exercise ................................................................. 69 4.7.2 Resistance exercise ............................................................................................... 70 4.8 Correlation between self-efficacy and aerobic exercise levels ........................................... 70 4.8.1 Self-efficacy and aerobic exercise levels at Exercise Clinic Session 1 ................ 70 4.8.2 Change in self-efficacy and aerobic exercise levels at Exercise Clinic Session 3 71 4.9 Descriptive pre/post measures ............................................................................................ 71 Chapter 5: Discussion ..................................................................................................................85 5.1 Exercise Clinic version 2.0 key components ...................................................................... 85 5.2 Change in aerobic and resistance exercise behaviours ....................................................... 87 5.3 Behaviour change techniques ............................................................................................. 89 x  5.4 Implementation into a “real world” clinical setting ............................................................ 91 5.5 Strengths, limitations and considerations ........................................................................... 93 Chapter 6: Conclusion .................................................................................................................97 References ...................................................................................................................................101 Appendices ..................................................................................................................................117 Appendix A   Prostate Cancer Supportive Care Program module structure ........................... 117 Appendix B Modified Godin Leisure Time Exercise Questionaire (GLTEQ) ....................... 118 Appendix C PCSC Program Aerobic exercise home program  .............................................. 119 Appendix D PCSC Program Aerobic exercise home program log sheet ................................ 121 Appendix E PCSC Program Personal History Questionnaire (PHQ) ..................................... 122 Appendix F Get Active Questionnaire (GAQ) ....................................................................... 123 Appendix G Exercise barriers and task self-efficacy questionnaire ....................................... 127 Appendix H Fatigue questionnaires: FACIT-Fatigue and Fatigue Visual Analogue Scale ... 129 Appendix I Exercise Clinic version 2.0 protocol: Data collection sheet ................................ 130 Appendix J PCSC Resistance training program example ....................................................... 133 Appendix K PCSC Program Exercise clinic participant results overview ............................. 137 Appendix L PCSC Program Exercise Clinic version 2.0 protocol 1-month data collection sheet................................................................................................................................................. 138 Appendix M Behaviour change techniques included in Exercise Clinic version 2.0 protocol139  xi  List of Tables  Table 1 Exercise Clinic version 2.0 protocol: evaluation pathway  ............................................. 61 Table 2 A priori feasibility definitions of Exercise Clinic version 2.0 protocol  .......................... 62 Table 3 Exercise Clinic version 2.0 protocol: Intervention  ......................................................... 63 Table 4 Participant baseline demographics  .................................................................................. 79 Table 5 Results of feasibility outcomes for exercise program  ..................................................... 80 Table 6 Change in weekly self-reported moderate-to-vigorous aerobic exercise levels across the exercise program ........................................................................................................................... 81 Table 7 Weekly resistance exercise volume of the Exercise Clinic version 2.0 protocol ............ 81 Table 8 Comparison fo Exercise Clinic version 1.0 and 2.0 protocols: exercise levels  .............. 82 Table 9 Correlation between self-efficacy score and aerobic exercise levels  ............................. 83 Table 10 Pre-post changes during Exercise Clinic version 2.0 protocol  ..................................... 84   xii  List of Figures  Figure 1 PCSC Exercise Clinic version 2.0 protocol: participant pathway  ................................. 60 Figure 2 Flow of participants through exercise program  ............................................................. 72 Figure 3 Attendance and attrition at each exercise session of the exercise proram  ..................... 73 Figure 4 Number of sessions of the exercise program that occurred within a priori session timing of the protocol  .............................................................................................................................. 73 Figure 5 Timing of each exercise program session  ..................................................................... 74 Figure 6 Fidelity of intervention delivery at each program session  ............................................. 75 Figure 7 Fidelity of the delivery of each intervention component  ............................................... 75 Figure 8 Weekly self-reported aerobic exercise levels of each program session  ........................ 76 Figure 9 Distribution of aerobic exercise levels of Exercise Clinic version 1.0 and 2.0 protocols at baseline and 3-months  .............................................................................................................. 76 Figure 10 Average aerobic exercise levels in Exercise Clinic version 1.0 and 2.0 protocols at baseline, 3-months and change at 3-months  ................................................................................ 77 Figure 11 Distribution of resistance exercise levels of Exercise Clinic version 1.0 and 2.0 protocols at baseline and 3-months  .............................................................................................. 77 Figure 12 Average resistance exercise levels in Exercise Clinic version 1.0 and 2.0 protocols at baseline, 3-months and change at 3-months  ................................................................................ 78  xiii  List of Symbols  β  Beta Δ  Delta or change =  Equals >   Greater than <  Less than /  Per %  Percent ±  Plus-minus rs  Spearman’s Correlation Coefficient v  Version xiv  List of Abbreviations  ADT   Androgen Deprivation Therapy BCT   Behaviour change technique BMI   Body mass index CI   Confidence interval CEP   Certified Exercise Physiologist CSEP   Canadian Society for Exercise Physiology ES   Effect size FACIT  Functional assessment of Chronic Illness Therapy FITT-VP  Frequency, intensity, time, type, volume, progression GAQ   Get active questionnaire GLTEQ  Godin leisure-time exercise questionnaire HAPA  Health action process approach HR   Hazard ratio ICC   Intraclass correlation coefficient MCID   Minimally clinically important difference  MET   Metabolic equivalent MINS   Minutes MOA   Medical office assistant  MVPA  Moderate-to-vigorous physical activity NHANES  National Health and Nutrition Examination Survey OR   Odds ratio xv  PA   Physical activity PCSC   Prostate Cancer Supportive Care  RCT   Randomized Controlled Trial RR   Relative risk SD   Standard deviation SMD   Standardized mean difference SOC   Stage of change SPPB   Short physical performance battery VAS   Visual analogue scale VCHRI  Vancouver Coastal Health Research Institute VO2peak  Peak oxygen consumption  xvi  Acknowledgements Firstly, I wish to acknowledge and thank my supervisor, Dr. Kristin L. Campbell, for her guidance, support, patience, mentorship and encouragement. You have fostered a supportive learning environment that values curiosity, discussion and collaboration, provides many opportunities, and ultimately, drives excellence. Thank you so much. It has been wonderful learning from you. I would also like to thank my thesis committee members, Dr. Celestia Higano and Dr. Guy Faulkner, for their input and guidance on this project and for their ongoing support.  To the PCSC Program, thank you for your research assistance, funding that made this possible, and for encouraging me as both a student and professional throughout this process. Phil Pollock, your input and guidance allowed this project to come to life. I also wish to thank the PCSC Exercise Working Group, whose collaboration created the 2.0 protocol. Thank you for being open to new ideas and for always pushing for excellence. To the patients of the PCSC Program, your positive energy is inspiring. Thank you for embracing the advice given to you during the exercise clinic and for being so amazing to work with.   To my fellow CEPL lab mates, past and present, and Rehabilitation Sciences graduate students, thank you all for your guidance and friendship throughout this journey. I also wish to thank my international support crew, especially Dr. Kate Bolam and Dr. Ciaran Fairman, who provided a safe place to discuss ideas and challenges along the way. To my colleagues at Treloar Physio Clinic, especially Deb Treloar, thank you for your patience as I completed this journey. I look forward to bringing new skills and ideas back into the clinic. Finally, I wish to thank the most important person in my life, my partner David, for his unwavering support throughout this chapter of our lives. Thank you for always being there, and for knowing when to drag me to the mountains to reset. More adventures await!   1  Chapter 1: Introduction Prostate cancer is the most prevalent male cancer in Canada, with one in nine men diagnosed in their lifetime.1 The average age of diagnosis in Canada is 67 years.1 Advances in screening techniques and medical treatments have led to high 5- and 10-year net survival rates in Canada, of 93% and 90% respectively.1 However, adverse treatment side effects such as fatigue and body composition changes commonly impact quality of life and physical function for years after treatment completion.2-6 Severity of treatment side effects is further exacerbated by the use of anti-androgen agents such as Androgen Deprivation Therapy (ADT), older age and high rates of physical inactivity.6-8 With many men living with prostate cancer rather than dying from it, strategies that reduce disease burden and support the long-term health and unique needs of prostate cancer survivors are required.8-10  Exercise is one strategy that has been shown to enhance survivorship and quality of life in prostate cancer survivors.11-15 Randomized controlled trials (RCTs) in individuals with prostate cancer consistently demonstrate aerobic and resistance exercise as safe and effective at managing and reducing adverse treatment side effects.13-17 Additionally, observational studies suggest that prostate cancer survivors who engage in higher levels of exercise have lower all-cause and prostate-specific mortality and slower prostate cancer progression, compared with less active individuals.18-23 Exercise recommendations for individuals with prostate cancer are the same as the public health guidelines for Canadian adults; a minimum of 150 minutes of moderate-to-vigorous aerobic exercise and two resistance exercise sessions weekly.24-27 Despite compelling evidence demonstrating the positive effects that exercise can yield, less than 25% of Canadian prostate cancer survivors currently meet these recommended exercise levels.28,29  2  Changing exercise behaviours is a complex process with many barriers identified across individual, organizational and environmental levels that influence exercise adoption and long-term exercise adherence.30-34 Known barriers to exercise adoption include a lack of access to services (e.g., inconvenient location, high costs, lack of referral), poor knowledge of exercise benefits (of patients and healthcare professionals), and treatment side effects (e.g., fatigue).13,30-32,35,36 However, research shows that individuals with prostate cancer have a high willingness to be active and that a window of opportunity for behaviour change or “teachable moment” may exist.28, 37-40 Considering that the majority of individuals with prostate cancer do not currently achieve the recommended weekly exercise levels, new efficacious approaches supporting exercise adoption and adherence are needed. Exercise interventions for individuals with prostate cancer have been shown to be most effective when they are supervised, delivered in an individual or group-based setting, and designed to meet the needs of the individual.15,41-43 However, these programs have implementation difficulties due to high costs, large space requirements and the need for highly qualified exercise professionals for program delivery.31 As a result, very few programs with these structural components that are most efficacious exist throughout Canada. Research has attempted to solve for this by using distance-based approaches for exercise support; specifically, the use of telephone consultations, home programming and web support.43 These approaches have demonstrated mixed outcomes related to exercise adoption, despite the broader participant reach that is typically achieved.43 Additionally, long-term adherence to exercise has not yet been shown in these delivery models.43 One strategy that has been previously underutilized in individuals with cancer that may prove both cost-effective and efficacious to promote the adoption and maintenance of exercise 3  behaviour in men with prostate cancer is exercise counselling.44-51 Exercise counselling has been previously described as a structured consultation that combines both motivational interviewing and cognitive behavioural approaches to promote physical activity and has traditionally been delivered by a medical doctor or allied health professional (i.e. nurse, physical therapist, exercise professional).52 In individuals with health conditions other than prostate cancer, exercise counselling has been shown to result in positive changes in exercise levels and related complex health behaviours (e.g., smoking cessation programs, diabetes prevention programs).53,54 While an exercise counselling approach does not provide supervised exercise, exercise counselling is commonly delivered in a face-to-face setting and designed to meet the needs of the individual, allowing it to encompass many elements of efficacious supervised exercise interventions.44-51 No previous studies have tested exercise counselling delivered by exercise professionals as an intervention option in individuals with prostate cancer in a real-world setting and few studies have explored exercise counselling more broadly across cancer survivors.48,51 Given the success of this approach in individuals with health conditions other than prostate cancer, there is value in exploring the feasibility and effectiveness of exercise counselling in individuals with prostate cancer.  In Vancouver, British Columbia, the Prostate Cancer Supportive Care (PCSC) Program is a multidisciplinary program that is available at no cost to individuals with prostate cancer.55,56 Offering both educational and clinical services through six unique modules, the PCSC Program is delivered by an expert clinical team including a nurse practitioner, physical therapist, registered dietitian, clinical exercise physiologist and clinical counsellor and is designed to support men and their families at all stages of prostate cancer. Module 3E, Exercise Support, was introduced in 2014 and has evolved over time. It currently includes a group education session 4  and a one-on-one exercise counselling clinic, delivered according to a set clinical protocol (PCSC Program Exercise Clinic version 2.0 protocol). The goal of the exercise counselling clinic is to assist with behaviour change and to increase the exercise levels of individuals with prostate cancer. This study evaluates the feasibility and preliminary effect of the current PCSC Program Exercise Clinic version 2.0 protocol.    5  Chapter 2: Background 2.1 Prostate cancer treatments Multiple treatment pathways exist for individuals with prostate cancer across the disease trajectory, from localized cancer to advanced metastatic disease, with treatments added as the disease state advances.57 For localized prostate cancer, three primary treatment options are commonly offered: surgery (e.g. prostatectomy), radiation therapy (e.g. brachytherapy or external beam radiation) and active surveillance (a process of actively monitoring the disease and progression without undergoing definitive therapy).58 A large RCT (ProtecT) by Hamdy et al (2016) published in the New England Journal of Medicine evaluated the 10-year survival of 1643 men with localized prostate cancer in the United Kingdom.59 Participants were randomized to active surveillance, surgery or radiation therapy and the results show no significant differences in survival at 10-years (1.5%, 0.9%, 0.7%, respectively).59 This study highlights one unique aspect of prostate cancer: multiple treatment pathways are available and newly diagnosed patients are often given a choice as to which treatment they would prefer to receive. For locally advanced prostate cancer, when the cancer has spread locally beyond the prostate gland into surrounding tissue in the prostate region, treatments can include external beam radiation therapy, hormone therapy (e.g. ADT) and surgery.57,58,60 ADT is an anti-hormone therapy that works by either lowering the testosterone produced by the testes or by blocking the binding to receptors, as prostate cancer usually requires androgen hormones (e.g. Testosterone) to proliferate or grow.60 As prostate cancer advances into a metastatic disease state (i.e. cancer has spread beyond the prostate region and throughout the body), treatments can include a combination of chemotherapy (e.g. Docetaxel plus Prednisone), radiation therapy (e.g. external beam or Radium-223), surgery (e.g. transurethral resection of the prostate) and hormone therapy 6  (e.g. ADT). 57,58,60 Over time prostate cancer can become ‘castrate resistant’ (i.e., ADT or surgical castration are no longer effective for controlling cell growth) and advanced anti-androgen agents (e.g. Abiraterone and Enzalutamide) can be administered to continue to treat and control the disease.57,58,60 One of the most common sites of prostate cancer metastasis or spread is to the bone.60 When bone metastasis are present, additional therapies such as bisphosphonates, radiation therapy (e.g. external beam or Radium-223) and monoclonal antibody therapy (e.g. Denosumab) are also commonly administered.58,60    2.2  Side effects of treatment Whilst extremely effective at prolonging life, each prostate cancer treatment elicits multiple adverse side effects that impact physical functioning and quality of life.2-8 Surgery (i.e. Radical Prostatectomy) can result in urinary incontinence and erectile dysfunction that can last from weeks to years.61-63 Some individuals will also experience climacturia, pain, lymphedema and inflammation after prostate surgery.61-63 Radiation therapy has been shown to sometimes result in erectile dysfunction, urinary issues (e.g. incontinence or urinary frequency), fatigue, bowel incontinence and skin irritation.61-63 A prospective population-based cohort study by Barocas et al (2017) evaluated 2550 men with localized prostate cancer 3-years after diagnosis and found the odds of erectile dysfunction, described as an erection insufficient for intercourse, was highest for men who received surgery (odds radio [OR] 3.4, 95% CI 2.5 – 4.6) compared to radiation therapy (OR 2.1, 95% CI 1.5 – 2.9) when controlling for baseline sexual function.62 In men who had sufficient baseline erectile function, only 43% reported erections sufficient for intercourse at 3-years post-surgery, which was significantly lower than those who had undergone radiation therapy and active surveillance (53% and 75%, respectively).62 Similar results were 7  also shown for urinary leakage.62 Individuals who had received surgery had higher odds of urinary leakage at 3-years when compared to those who received active surveillance (OR 2.9, 95% CI 1.8 – 4.7) or radiation therapy (OR 4.5, 95% CI 2.7 – 7.3).62 Additionally, an evaluation of patient-reported outcomes by Donovan et al (2016) from the ProtecT trial showed that although some recovery of urinary continence was seen over time, in those who received surgery, only 31% reported complete continence at 6-years compared to ~50% for the active surveillance and radiation groups.63  It is estimated that approximately 50% of individuals with prostate cancer will be administered ADT at some point.64 ADT is usually administered for a set time-frame (e.g. 12-months) for locally advanced prostate cancer, intermittently (i.e. breaks given for months/years when the disease appears controlled) for prostate cancer that progresses or recurs, or continuously for advanced prostate cancer.64 ADT has been shown to be associated with increased risk of cardiovascular death (hazard ratio [HR] 1.17, 95% CI 1.07 – 1.29), cardiovascular morbidity (HR 1.37, 95% CI 1.29 – 1.46), diabetes (RR 1.36, 95% CI 1.07 – 1.74), increased metabolic complications (e.g. impaired insulin sensitivity and increased cholesterol), cancer-related fatigue, mood disorders, reduced penile and testicular size, gynecomastia, hot flashes, anemia, and impaired cognition.7,64-70 Additionally, changes to body composition are common during and after ADT, including decreased bone mineral density (3-10% reduction in the first 12-months), decreased muscle mass (2-4% reduction in the first 12-months) and increased fat mass (11-20% over 3-years).65-70 Higher fracture rates have also been reported in men receiving ADT compared to men with prostate cancer who did not receive ADT (relative risk [RR] 1.23, 95% CI 1.1 – 1.38) and also when compared to age-matched controls.67,68 Additionally, results show that 2-years after treatment cessation, pre-treatment 8  levels of fat mass and lean mass are not usually recovered, even when normal testosterone levels return.69,70 For more advanced prostate cancers, advanced anti-androgen agents can also elicit the same side effects as ADT, with the addition of pain, hypertension and possible seizures.58  Treatment with chemotherapy is commonly reserved for metastatic prostate cancer. The side effects of chemotherapy administered to individuals with prostate cancer include fatigue, nausea, diarrhea, reduce blood cell counts (i.e. bone marrow suppression), loss of appetite, and hair loss.60 Similar side effects are also seen from medications given for bone metastases, with the addition of pain, specifically in muscles, joints or bones.60 Considering that prostate cancer survivors usually receive multiple treatment modalities, these factors, combined with the older age of prostate cancer survivors at diagnosis and the inactivity of this population, add complexity to the physical presentation and overall needs of individuals with prostate cancer.58,60,66   2.3 Exercise management of treatment side effects  Exercise is a specific type of physical activity that is planned, structured and repetitive, performed with the intention of improving health or fitness.71,72 Across all stages of prostate cancer exercise has been shown to be a safe and effective intervention that can improve quality of life, overall physical function and side effects of treatments.11-17 In a meta-analysis by Bourke et al (2016) evaluating the effect of resistance and aerobic exercise in prostate cancer survivors who had received any type of treatment, 1574 participants were evaluated from 16 RCTs.13 The majority of RCTs included supervised aerobic and resistance exercise interventions, 2- to 4-days per week, with follow-up periods ranging from 8-weeks to 12-months.13 The results show a moderate positive effect of exercise for cancer-specific quality of life (standardized mean difference [SMD] 0.33, 95% CI 0.08 – 0.58), cancer-specific fatigue (SMD 0.45, 95% CI 0.22 - 9  0.67), sub-maximal aerobic fitness (SMD = 0.49, 95% CI 0.12 – 0.85) and lower body strength (SMD = 0.34, 95% CI 0.07 – 0.60).13 Significant improvements were also observed in upper body strength (SMD 0.26, 95% CI 0.02 – 0.51) and borderline significant positive effects were found for exercise tolerance (VO2peak) (SMD 0.27, 95% CI 0.00 – 0.54) and sexual activity (SMD 0.37, 95% CI 0.00 – 0.73). No effect was seen for sexual function, blood pressure or disease progression.13  A similar meta-analysis by Yunfeng et al (2017) evaluated the effect of exercise in 1135 men who were initiating ADT.14 In this study exercise was evaluated across two separate categories, interventions lasting less than 6-months and interventions of greater than 6-months, to understand the effect of exercise intervention length.14 For interventions less than 6-months, exercise improved upper body strength (SMD 0.71, 95% CI 0.50 – 0.92), lower body strength (SMD 0.78, 95% CI 0.57 – 0.99), exercise tolerance (VO2peak) (SMD 0.35, 95% CI 0.04 – 0.66), body mass index (BMI) (SMD -0.33, 95% CI -0.55 – -0.12), and sexual function (SMD 0.66, 95% CI 0.35 – 0.97).14 Exercise had non-significant effects on fatigue in interventions lasting less than 6-months, but had significant effects for interventions longer than 6-months (SMD -9.3, 95% CI -16.22 – -2.39).14 No benefits of exercise were found related to bone health or cardiometabolic changes.14 Furthermore, resistance exercise and aerobic exercise training were each shown to be effective at independently eliciting improvements in obesity, fatigue and exercise tolerance, suggesting that both exercise types can be effective intervention options.13,14    The type of exercise that is most beneficial has not been examined in the same way as other cancers, namely aerobic alone, resistance alone, or the combination. The prevalence of ADT treatment and resulting issues with loss of lean muscle mass has resulted in the majority of RCTs in prostate cancer survivors focusing on resistance training, with or without aerobic 10  exercise, with two meta-analysis specifically evaluating this area.16,73 Keilani et al (2017) included 1199 individuals who had received any type of prostate cancer treatment, from 17 trials, the majority of which were RCTs and the remainder single-arm prospective studies.16 Chen et al (2019) evaluated 468 individuals receiving ADT from seven RCTs.73 Both evaluations show increases in upper body strength (SMD 5.24kg, 95% CI 2.52 – 7.97kg; SMD 3.15kg, 95% CI 2.46 – 3.83), lower body strength (SMD 28.2kg, 95% CI 10.51 – 45.88kg; SMD 3.15, 95% CI 2.46 – 3.83), with the ADT-only study showing smaller improvements.16,73 Additionally, Keilani et al (2017) found improvements in lean body mass (SMD 1.0%, 95% CI 0.15 – 1.84%; ), body fat percentage (SMD -0.66%, 95% CI -0.79 – -0.53) and physical function, measured by the 400m walk test (SMD -18.1s, 95% CI -21.55 – -14.65s) in men who had received various treatments, whilst Chen et al (2019) showed no change in lean mass (SMD 0.49, 95% CI -0.76 – 1.74, p=0.44) in men receiving ADT.16,73 The majority of studies included supervised resistance exercise for 8- to 52-weeks at intensities of 60 to 85% of 1-reptition maximum (RM) with 2- to 4-sets of 6- to 15-reps.16,73 These results highlight the efficacy of supervised resistance exercise for prostate cancer survivors, even when receiving ADT.16,73 Keilani et al (2017) noted that limited evidence is currently available regarding resistance exercise performed from home-based environments, but it appears to be more difficult to perform and adhere to without supervision.16  Furthermore, Chen et al (2019) note that the majority of studies included exercise interventions that started 6+ months after ADT initiation, meaning a loss of lean mass had already occurred, and the potential impact of intervention timing on lean mass preservation during ADT is unknown.73   A recent RCT by Taaffe et al (2019) explores this idea of exercise intervention timing further in 104 men receiving ADT.74 One group started exercise at ADT onset (intervention 11  group) and the other group was delayed until 6-months after ADT onset (delayed group).74 Both groups received a 6-month supervised intervention that included resistance exercise, aerobic exercise and impact exercise of moderate-to-vigorous intensity performed three times per week.74 The study found that commencing supervised exercise at ADT onset preserved muscle mass and muscle density at 6-months (p<0.001 for lean mass and p=0.016 for muscle density for effect of time) when compared to the delayed group.74 However, the delayed exercise group were able to recover muscle mass and muscle density after 6-months of exercise training. The final 12-month evaluation showed no difference between groups, however, the intervention group had been unsupervised and unsupported for the final 6-month period when the delayed group received supervised exercise.74 It is unknown if greater effects would have been seen if the intervention group continued supervised exercise for the entire 12-months. These results highlight the potential effectiveness of combined exercise programs (resistance plus aerobic plus impact exercise) on muscle strength and density, and that more research is required to better understand the most effective support and timing of exercise in men receiving ADT.73,74   2.4 Impact of exercise on survival and prostate cancer progression Beyond the management of prostate cancer treatment side effects, the impact of exercise on overall survival and prostate cancer specific mortality has been examined by epidemiological studies.18-22 Higher levels of self-reported physical activity are consistently associated with a risk reduction for overall survival (HR ranging from 0.51 to 0.63, 95% CI 0.36 - 0.79), prostate specific mortality (HR ranging from 0.39 – 0.69, 95% CI 0.18 – 0.95) and progression (HR 0.43, 95% CI 0.21 – 0.91).18-23 The study with the longest follow-up period is a prospective cohort study by Friedenreich et al (2016) with a 17-year follow-up of 830 men with stage II-IV prostate 12  cancer.18 Higher total physical activity levels after diagnosis (>119 vs <42 MET-hr/week) was associated with lower all-cause mortality risk (HR 0.58, 95% CI 0.42 – 0.79).18 Additionally, higher recreational activity after diagnosis (>26 vs <4 MET-hr/week) was found to be associated with lower prostate-specific mortality risk (HR 0.56, 95% CI 0.35 – 0.90).18 In a large epidemiological study by Kenfield et al (2011) using Health Professionals Follow-up Study data (n=51,529), men diagnosed with non-metastatic prostate cancer (n=2,705) were evaluated at 2-year intervals for up to 18 years, with a specific focus on physical activity volume and intensity.19 Men reporting three or more hours per week of vigorous activity had a lower risk of all-cause and prostate-specific mortality (HR 0.51, 95% CI 0.36 – 0.72; HR 0.39, 95% CI 0.18 – 0.84, respectively) when compared to men reporting less than 1-hour per week of vigorous activity.19 For non-vigorous activity, men reporting durations of five or more hours per week had lower all-cause mortality risk when compared with those reporting less than one hour per week (HR 0.72, 95% CI 0.58 – 0.95), with greater risk reductions shown for those achieving 10 or more hours per week (HR 0.49, 95% CI 0.37 – 0.71).19 These results highlight the association of larger amounts of vigorous activity with reduced prostate-specific mortality risk and of higher volumes of non-vigorous activity with reduced all-cause mortality risk.19  Limited research exists that explores exercise volume and prostate cancer disease progression, with two prospective cohort studies in this area that both evaluate vigorous-intensity exercise, one prior to diagnosis (Dai et al, 2019) and one in exercise after diagnosis (Richman et al, 2011).20,23 In a cohort of 1354 men with localized prostate cancer, pre-diagnosis vigorous exercise at least once per week was associated with lower rates of metastatic lethal progression (HR 0.63, 95% CI 0.42 – 0.95).23 No difference was found between those who exercised vigorously one to three times per week and those who exercised vigorously more than three 13  times per week.23 In a cohort of 1455 men with localized prostate cancer, post-diagnosis vigorous-intensity exercise, specifically walking briskly (>3mph) for three or more hours per week, was associated with a lower rate of prostate cancer progression when compared to men who walked at an easy pace (<3mph) (HR 0.43, 95% CI 0.21 – 0.91).20 In addition, a faster walking pace was shown to be associated with a decreased risk of prostate cancer progression independent of walking duration (HR 0.52, 95% CI 0.29 – 0.91).20 Both of these studies suggest that vigorous-intensity exercise may reduce the risk of prostate cancer progression and that it is the intensity, not the frequency or duration, that appears to be important.20,23  Currently, the epidemiological studies highlight the potential impact that longer duration and higher intensity physical activity may elicit in prostate cancer survivors related to overall survival, prostate-specific mortality and prostate cancer recurrence.18-23 To date there have not been any RCTs in men with prostate cancer that test the impact of exercise on survival or recurrence outcomes. However, one is currently underway (INTERVAL-GAP4) by Newton et al (2018) that is evaluating the effect of supervised high intensity aerobic and resistance exercise on overall survival in patients with metastatic castrate-resistant prostate cancer.75 The results of this trial may provide key evidence on the level of efficacy that aerobic and resistance exercise can yield on survival in individuals with advanced prostate cancer.75  2.5 Ability of individuals with Prostate cancer to meet exercise recommendations  Recommendations for cancer survivors to engage in regular exercise are consistent across multiple international cancer or exercise organizations, encouraging all cancer survivors to avoid inactivity and to build up to meet the aerobic and resistance exercise levels recommended for adults in standard public health guidelines.24-27 In Canada, this includes achieving a minimum of 14  150 minutes of moderate-to-vigorous aerobic exercise and two resistance exercise sessions weekly.25 Despite strong evidence supporting the safety and efficacy of exercise in individuals with prostate cancer, evaluations of this population show that the majority of prostate cancer survivors are insufficiently active.28,29,37,38,76-78  The reported proportion of individuals with prostate cancer who meet the aerobic and resistance exercise guidelines varies based on the method used to evaluate exercise levels (objective or self-reported).28,33,37,76-78 The majority of studies report only on aerobic exercise levels and generally find that individuals with prostate cancer are performing insufficient amounts of moderate-to-vigorous aerobic exercise or physical activity (depending on measurement and definition).33,37,77 One of the larger studies in prostate cancer is a cross-sectional study by Chipperfield et al (2013) that evaluated the aerobic exercise levels of 365 Australian men who had previously received radiation therapy for prostate cancer.33 Results show that 42% of prostate cancer survivors self-reported meeting aerobic exercise guidelines.33 Lower aerobic exercise levels were associated with those receiving ADT, and in participants with more comorbidities, lower education levels and higher levels of depressive symptoms.33 In one of the few evaluations of resistance exercise levels in prostate cancer survivors, a cross-sectional study by Forbes et al (2015) evaluated 253 Canadian prostate cancer survivors, of which the majority had previously received surgery and/or radiation therapy.29 Results show that only 23% of individuals with prostate cancer met resistance exercise guidelines.29  Only three studies have evaluated both aerobic and resistance exercise levels in men with prostate cancer,28,76,78 A prospective cohort study by Galvao et al (2015) in 463 Australian prostate cancer survivors post-curative treatment (surgery and/or radiation therapy and/or ADT) 15  found 12% met both aerobic and resistance exercise recommendations and 33% met aerobic exercise guidelines.76 Inactive men were older, had greater waist circumference, higher levels of distress and higher overall supportive care needs compared to sufficiently active men.76 A similar cross-sectional study by Ottenbacher et al (2015) used information from the Health Information National Trends Survey (HINTS) and evaluated exercise levels of United States prostate cancer survivors and males without cancer.78 Results show that 19% of individuals with prostate cancer met both aerobic and resistance exercise guidelines, 44% met aerobic exercise guidelines and 31% met resistance exercise guidelines.78 These results were not significantly different when compared to men who had no history of cancer, when adjusted for covariates (age, race, education).78 In a recent cross-sectional study by our team (Weller et al, 2019) in 103 Canadian prostate cancer survivors who had mixed treatment status and type, 24% of individuals with prostate cancer met both aerobic and resistance exercise guidelines.28 Results show that 56% met aerobic exercise guidelines, 40% met resistance exercise guidelines and 28% met no exercise guidelines.28 This study also found that the presence of additional health challenges (e.g. comorbidities) reduced the likelihood of meeting aerobic exercise guidelines, but did not appear to impact resistance exercise levels of this sample.28 Overall, these studies suggest that 12 to 25% of prostate cancer survivors meet both aerobic and resistance guidelines.28,76,78 All of the studies mentioned above used self-reported exercise levels. It has been previously shown that using self-reported measures of aerobic exercise may lead to an over-report of both exercise levels and exercise intensity compared to objectively reported measures of aerobic exercise (e.g. accelerometers).79 This suggests that using self-reported levels of exercise leads to higher perceived compliance to guidelines than objectively reported measures 16  would show. However, self-reported levels of exercise are more commonly used in clinical practice and research studies due to the ease of application of self-report methods compared to objective measures.80 One of the few studies that evaluated objectively measured aerobic exercise levels of prostate cancer survivors (Thraen-Borowski et al, 2017) used NHANES data and found that only 13% were achieving the aerobic exercise guidelines.81 On average, prostate cancer survivors were accumulating 96 minutes of moderate-to-vigorous exercise per week (95% CI 67 – 125).81 Overall, the available research to date suggests that the proportion of individuals with prostate cancer who meet both aerobic and resistance exercise guidelines is low.28,29,33,76-78,81 This number may in fact be even lower than reported based on reliance of self-report data, further supporting the need for interventions that improve exercise adoption and maintenance.  2.6 Exercise adoption in men with prostate cancer Whilst the current literature shows poor compliance of individuals with prostate cancer to exercise guidelines, there is also evidence that shows a high willingness to exercise.28,37,38 A mixed methods study by Harrington et al (2013) involving structured interviews and a cross-sectional evaluation in 135 prostate cancer survivors receiving ADT looked at the acceptability of physical activity participation and determined the percentage of participants meeting national exercise guidelines.37 Results show a high willingness to participate in aerobic (79%) and resistance (81%) exercise programs.37 This study also evaluated aerobic exercise levels of participants and found that despite their willingness to be active, only 19% of participants were meeting the aerobic exercise guidelines.37 In a more recent cross-sectional study by our team (Weller et al, 2019) of 103 men with heterogeneous prostate cancer treatment history, similar 17  results were seen.28 The majority  of participants (78%) were interested or unsure of their interest regarding participation in aerobic and resistance exercise, and only 24% self-reported meeting exercise guidelines.28 A recent systematic review by Wong et al (2018) explored the exercise programming preferences of cancer survivors from 41 studies and also found that most studies reported cancer survivors were interested in participating in an exercise program, despite the majority not meeting exercise guidelines.38 This highlights that an intention-behaviour gap is present in prostate cancer survivors related to exercise. Bridging the gap between intention and behaviour is a complex field of study that draws heavily upon behaviour change theories to better understand what impacts an individual’s preferences, barriers, facilitators and actions related to physical activity or other health behaviours.82,83 Research specific to prostate cancer shows that prostate cancer survivors face unique barriers to exercise adoption that vary based on treatment type and length (e.g. ADT), disease state (e.g. metastatic) and time since treatment.28-35 Increasing age and a higher number of comorbidities are two barriers that appear to be consistent across all disease stages in prostate cancer.30,32,84 In individuals with metastatic prostate cancer, barriers to exercise can also include pain (e.g. at the location of a bone metastasis), fatigue from advanced treatments and fear of injury.13,84,85 Men receiving ADT have been shown to have barriers associated specifically with fatigue, lack of motivation and lack of specific exercise advice to manage side effects of ADT.30 In individuals who have completed treatments for more localized and locally advanced prostate cancer (stage I – III), the main barriers to exercise include comorbidities, physical decline due to aging (e.g. joint pain), lack of time and lack of confidence.32 It is thought that by understanding 18  the unique barriers that prostate cancer survivors experience, exercise programming can be tailored to better meet the needs of individuals with prostate cancer.28-32 Exercise facilitators are another area that may assist in improving exercise behaviours of individuals with prostate cancer.30 Commonly reported facilitators to exercise in individuals with prostate cancer include clinician involvement, spousal support, group-based programs, qualified exercise professionals (i.e. exercise physiologists) and peer support.30-37,42 In a qualitative focus group study by Keogh et al (2014) in men who were and were not receiving ADT, individuals with prostate cancer were reported to value clinician involvement and believed this was a main facilitator to physical activity.30 Spousal involvement was also a key facilitator, particularly regarding having a physical activity partner and discussing physical activity intentions.30 A similar qualitative study by Cormie et al (2015) using semi-structured interviews in 12 men who had received ADT and participated in an exercise intervention found that exercise facilitators included peer support, health benefits related to physical and mental well-being, and support from exercise physiologists.42 Another qualitative study by Sutton et al (2017) used semi-structured interviews in men with localized prostate cancer reported that participants believed their compliance to physical activity advice would be improved if clear and evidence-based information supporting the advice from healthcare professionals was provided.86 Additional facilitators included the information coming from a credible source (e.g. a professional who was also implementing the advice themselves).86 Similar to previous studies, the authors also noted that prostate cancer survivors indicated they would prefer receiving advice at an early stage of their treatment.86,87    Beyond exercise facilitators, understanding predictors of adherence to an exercise 19  intervention in prostate cancer survivors may assist with providing intervention adaptations and appropriate support for those at risk of non-adherence.88-90 A recent systematic review by Ormel et al (2018) in 2279 cancer survivors from 15 studies explored the predictors of adherence to exercise interventions during and after cancer treatments.88 Broadly, for cancer survivors receiving cancer treatments, predictors of adherence included location of the centre, having extensive exercise history, high motivation for exercise and fewer exercise limitations.88 After cancer treatments, predictors of adherence included less extensive surgery, low alcohol consumption, high previous exercise, family support, feedback by trainers and having knowledge and skills of exercise.88 However, the majority of the 15 included studies were in women and only one included prostate cancer survivors, so more research into the potentially unique predictors of adherence in men, and in men with prostate cancer is needed.88 Only two RCTs have explored predictors of exercise adherence among prostate cancer survivors.89,90 Courneya et al (2004) looked specifically at predictors of adherence to a 12-week resistance exercise intervention in 82 men receiving ADT.89 Pre-program exercise stage (based on the transtheoretical model), exercise intention and age explained 20% of the variance of exercise adherence, with each factor also being identified as an independent predictor of exercise adherence (stage: β 0.26, P=0.13; age β -0.22, p=0.37; intention β 0.19, p=0.073).89 Craike et al (2016) evaluated exercise predictors from a cluster RCT of a clinician-referred 12-week exercise program in 52 men with stage I to III prostate cancer who had completed primary treatments or who were receiving ADT.90 Men who experienced more severe hormonal symptoms were associated with lower levels of exercise adherence (β -0.48, P=0.05, 95% CI –97 to 0.009), and men with more positive role functioning (e.g. the patient’s ability to pursue activities such as 20  work or leisure) were associated with higher levels of exercise adherence.90 These findings highlight the unique predictors of adherence that exist for prostate cancer survivors, compared to those found in other cancer survivors, which should be taken into consideration when prescribing exercise to this population.88-91 Finally, when considering exercise adherence, some research suggests that understanding the preferences of individuals with prostate cancer may help to tailor program offerings.37-39,47,77 However, a recent systematic review by Wong et al (2018) in cancer survivors highlights that caution should be used when interpreting exercise preference data, as participants less familiar with exercise may not know their exercise preferences.38 A recent cross-sectional study by members of our research team (Weller et al, 2019) supports this idea, reporting different exercise preferences in prostate cancer survivors who met exercise guidelines, compared to those who did not meet exercise guidelines.28 Participants who were not meeting the combined aerobic or resistance exercise guidelines were less likely to be interested in group-based exercise, exercise at a community centre or gym, or in resistance exercise.28 In contrast, participants who were meeting both guidelines were more likely to be interested in resistance exercise, more likely to be interested in participating in group exercise, and less likely to prefer home-based exercise.28 One qualitative study by Jackson et al (2018) using semi-structured interviews explored this concept in head and neck cancer patients who had participated in a 12-week RCT involving twice weekly exercise. They found that after participation in an exercise program significant increases were seen in preferences towards exercise at a cancer centre and with other cancer survivors.92 The need to encourage individuals to consider trying exercise programming approaches that may be outside their current preferences may be important when considering development of exercise programming that addresses the needs of prostate cancer survivors and 21  promotes positive behaviour change over time.  2.7 Long-term adherence to exercise in men with prostate cancer   Exercise interventions for individuals with prostate cancer commonly show positive improvements during the intervention period that lessen once the intervention has finished, especially after supervised exercise programs.13-17 For ongoing health benefits individuals are required to maintain regular performance of exercise.93 Research trials have established the efficacy of short-term, supervised exercise interventions of 8-weeks to 12-months in duration, at a frequency of two to four sessions weekly.13-17 However, less is known about maximizing long-term exercise adherence (i.e. periods greater than 1-year) after a supervised intervention ends.34,93,94 Additionally, whilst some studies report follow-up data for aerobic exercise levels, no study currently exists that includes a prostate-only cohort and reports the follow-up adherence of resistance exercise.94 Given the high survival rates, long treatment administration periods and extensive side effects caused by prostate cancer treatments, strategies are needed to support long-term adherence to exercise that can be implemented into routine clinical practice.13,31 A prospective cohort study by Stone et al (2019) in 830 men with stage II to IV invasive prostate cancer evaluated the determinants of changes in physical activity from pre-diagnosis to post-diagnosis.93 Non-exercisers, when compared to those who maintained exercise levels post-diagnosis, were more likely to be associated with being employed (OR 2.0, 95% CI 1.32 – 3.04), smoking (OR 2.36, 95% CI 1.58 – 3.54), have a high PSA at diagnosis (OR 1.52, 95% CI 1.05 –2.22), based in a rural location (OR 2.36, 95% CI 1.58 – 3.54) and having below average physical quality of life (OR 2.34, 95% CI 1.54 – 3.55).93 Individuals were less likely to be non-22  exercisers if they attended a support group or counselling (OR 0.48, 95% CI 0.29 – 0.79). Non-exercisers, when compared to those who adopted exercise after diagnosis, were more likely to be associated with having urinary incontinence (OR 1.51, 95% CI 1.02 – 2.23), smoking (OR 1.88, 95% CI 1.07 – 3.3) and below average quality of life (physical and mental) (OR 2.0, 95% CI 1.29 – 3.10).93 Men who stopped exercise after diagnosis were more likely to be associated with living in rural locations (OR 1.92, 95% CI 1.09 – 3.38) and those less likely to relapse reported having social support (OR 0.56, 95% CI 0.33 – 0.96).93 The authors conclude that many demographic, medical, lifestyle and quality of life variables are associated with the exercise behaviours and patterns of prostate cancer survivors.93 To best elicit positive exercise behaviours in prostate cancer survivors after diagnosis, this study suggests that strategies should be used that mitigate barriers, address detrimental determinants and implement programs that support inactive individuals to adopt exercise and active individuals to maintain exercise.93   An updated Cochrane review by Turner et al (2018) including 23 RCTs and 1372 participants evaluated interventions promoting habitual exercise in cancer survivors.34 Studies showing better exercise adherence at 6-months shared three similarities; 1) clear program goals, 2) encouragement to transfer supervised behaviours into unsupervised contexts and 3) exercise programs based around individual capabilities.34 Studies with >75% adherence to an intervention that met exercise recommendations were consistent in including a component of supervised exercise and incorporating behaviour change techniques (BCTs) such as goal setting, setting graded tasks and instruction of how to perform a behaviour.34 Evidence from this review suggests that adherence to exercise was sustained at 6-months follow-up (SMD 0.56, 95% CI 0.39 – 0.72, 7 studies, 591 participants), however, the authors note that caution should be used 23  with the interpretation of these findings due to high risk of bias (i.e. randomization procedures and blinding not reported) and low quality evidence (i.e. small sample sizes).34 These findings support the idea that exercise interventions which are successful at maintaining adherence to exercise post-intervention include specific BCTs, teach the skills necessary for independent exercise and adapt programming to the individuals’ needs.95-98   2.8 Outline of Behaviour Change Techniques (BCTs) for interventions with cancer survivors  Behaviour change interventions are often complex, with many components, described in the literature as “active ingredients”, included to drive mechanisms through which behaviour change can occur.95 To assist in providing a common language to better describe BCTs, a standardized classification system was created by Michie et al (2013) that describes intervention techniques, BCT v1 Taxonomy.95 A BCT is defined as “an observable, replicable, and irreducible component of an intervention designed to alter or redirect causal processes that regulate behaviour; that is, a technique is proposed to be an active ingredient”.95 The identification of BCTs in interventions can assist in understanding the mechanism of effect and enhance understanding of the components that make an intervention successful or unsuccessful at changing behaviour.95 A refined 40-item taxonomy specific to physical activity and healthy eating behaviours, the CALO-RE taxonomy, has also been widely used in physical activity evaluations to better understand the active ingredients of behaviour change interventions.96  A meta-analysis by Finne et al (2018) included 30 studies and 4507 cancer survivors and evaluated the effectiveness of various BCTs at increasing physical activity in cancer survivors.97 24  Seven of the included studies included prostate cancer survivors.97 Results show that five individual BCTs were associated with interventions that increased physical activity levels, namely, including prompts or cues (e.g. telephone calls, pedometer), gradually reducing frequency of prompts/cues over time, setting graded tasks (e.g. increasing exercise frequency or difficulty over time), non-specific rewards (e.g. immediate reinforcement via automated message for goal achievement) and social rewards (e.g. praise for achievement).97 The number of BCTs included in an intervention did not predict the change in physical activity achieved (estimated increase per additional BCT, effect size [ES] 0.005, 95% CI -0.01 – 0.02).97 Intervention delivery in a combination of home-based and facility-based settings was associated with the largest effects (ES 0.39, 95% CI 0.28 – 0.49), compared to interventions that delivered only home-based (ES 0.26, 95% CI 0.14 – 0.39) or only facility-based interventions (ES 0.04, 95% CI -0.07 – 0.14).97  One systematic review by Hallward et al (2018) explored the BCTs used in 15 physical activity or exercise interventions for men with prostate cancer at all stages post-diagnosis.98 Each study was classified into promising and non-promising categories, based on the potential of the intervention to increase physical activity levels.98 Interventions lasted from 2- to 12-months, with most incorporating exercise interventions that included aerobic and resistance exercise delivered from facility and home-based settings and supervised in facilities by an accredited exercise physiologist or kinesiologist.98 Six studies were classified as using promising interventions that increase physical activity levels, five were unclear and four were classified as non-promising.98 No significant difference was seen in the number or types of BCTs included in promising and non-promising interventions.98 Three BCTs appeared in promising interventions only, namely 25  social support (e.g. through supervised exercise and group-based settings), prompts and cues (e.g. booster sessions, telephone calls) and information about antecedents (e.g. making individuals aware of situations and emotions that can predict engagement in physical activity).98 The authors noted that in the six promising interventions, each BCT was either taught to the participant by those delivering the intervention or actively discussed with the participant (e.g. setting a goal or problem solving how to overcome a barrier), suggesting that the quality of BCT delivery may be more important than BCT type.98 They conclude that prostate cancer survivors may have a better response to programs or providers who go beyond just providing information, and instead teach, discuss and explain the BCT and how it may help them change their exercise behaviour.98  A recent mixed methods study by Mazzoni et al (2019) in breast, colorectal and prostate cancer survivors receiving treatment included interviews (n=19, prostate cancer 39%) and questionnaires (n=229, prostate cancer 20%) related to exercise behaviour change support during cancer treatment.99 Participants had completed or dropped out of a 6-month exercise intervention that included either low-to-moderate or high-intensity exercise, with or without additional behaviour change support.99,100 The study found that intrinsic motivation was enhanced through a program that combined exercise (supervised and home-based) and behaviour change support.99 The BCT’s most valued by participants for supervised resistance exercise were social support from coaches, structuring the physical environment with scheduled sessions, self-monitoring with log books and feedback with testing (median of all = 5/5, “very valuable”).99 For home-based endurance training, the BCTs most valued by participants were social support from coaches and feedback with use of heart rate monitor and fitness testing (median of all = 5/5, 26  “very valuable”).99 The authors conclude that the results reflect the importance of fostering autonomy, competence and relatedness to facilitate the adoption of exercise during cancer treatments.99   A recent meta-analysis by Grimmett et al (2019) evaluated the BCTs of 27 physical activity behaviour change interventions that reported follow-up data of at least 3-months in 3122 cancer survivors, with 4 studies including men with prostate cancer.101 The median levels of moderate-to-vigorous physical activity (MVPA) was 86 mins/week at baseline and increased by a mean of 65.3 mins/week (95% CI 45.6 – 85.0) at post-intervention follow-up with a moderate effect reported (SMD 0.49, 95% CI 0.32 – 0.66).101 Based on the post intervention follow-up change in MVPA, studies were classified as ‘very promising’ (significant between group difference), ‘quite promising’ (within group differences reported) and ‘not promising’ (neither within nor between group differences reported).101 Few distinct differences were seen between studies classified as ‘very promising’ or ‘quite promising’ when compared to ‘not promising’, with the more promising studies including graded tasks (i.e. starting easy and gradually making the task more difficult), social support (e.g. praise or reward for performance of behaviour) and action planning (i.e. detailed plan of how to perform the behaviour).101 The majority of successful interventions included young and well-educated participants, while in contrast two of the six ‘not promising’ interventions were comprised entirely of prostate cancer survivors, suggesting that they may have unique needs due to their older age and treatment side effects that could play a key role in changing physical activity behaviours.101 The authors suggest that future interventions should consider a stepped care approach to intervention design (e.g. more support delivered to those with higher needs) to better assist older cancer survivors and those from less 27  educated backgrounds.101 Overall, evaluating the use of BCTs within interventions in individuals with prostate cancer is an emerging area of research which may add to our understanding of the mechanisms of action that drive increased physical activity behaviours and the intervention structures that are required to achieve this.95-101   2.9 Implementation of exercise for prostate cancer survivors into clinical settings Looking beyond the individual factors related to exercise behaviours of prostate cancer survivors, research also shows that many barriers exist for successful implementation of exercise services into clinical care.9,31,102 In Canada, it has been identified that oncology rehabilitation programs are not meeting the exercise and rehabilitation needs of cancer survivors.31,102 Further, a previous Canadian study by Santa Mina et al (2015) using semi-structured interviews with key personnel from cancer-exercise programs outlines the experience of implementing exercise programming within a large tertiary healthcare centre, namely inadequate referral pathways, lack of access to qualified professionals and a lack of space and equipment.31 A cross-sectional study by Canestraro et al (2013) into oncology rehabilitation provision and practice patterns across Canada reported that the majority of Canadian facilities who offer cancer treatment or rehabilitation do not feel that they are meeting their patients’ rehabilitation needs.102 The main reported barriers to the development of oncology rehabilitation programs were funding and resource availability (e.g. space and qualified staff).102 A narrative review by Phillips et al (2014) exploring strategies to accelerate the implementation of cancer-specific exercise research into practice recommends that a broader lens should be used to achieve impact and successful program implementation from research 28  studies.103 The authors encourage researchers to consider the larger translational context of their findings, more specifically, to include relevant stakeholders, explore different study designs and to be more collaborative, contextual, integrated and representative regarding both the participants and the setting the intervention will be implemented within.103 This is echoed in a commentary article by Alfano et al (2014) that reports on discussions from a meeting of key stakeholders in cancer rehabilitation hosted by the American Cancer Society meeting.104 The commentary provides an action plan for translating cancer survivorship research into care.104 Additionally, it reinforces that cancer survivors have complex needs and that to support the adoption and long-term adherence of exercise behaviours, a higher level coordinated approach that includes collaboration between all stakeholders is required within survivorship care.104    A narrative review by Cheville et al (2017) provides an overview of the current need, delivery models and levels of care in cancer rehabilitation and proposes that models of care could be developed that address the needs of cancer survivors in a ‘one-stop shop’ approach to supportive care programming (e.g. hospital setting).9 The authors highlight that cancer survivors have limited time and energy resources (e.g. amount of treatment and medical appointments, along with burden of treatment symptoms), limited fiscal resources (e.g. time off work, out of pocket expenses) and their immediate support systems (e.g. spouse or family) are often over-utilized.9 The provision of supportive care programming from clinical settings may be one way to overcome these common barriers to accessing exercise or rehabilitation services. This approach was tested by Bultijnck et al (2018) in prostate cancer survivors receiving ADT through the implementation of a clinical pathway triage tool within a hospital setting.10 The tool guided a risk assessment screening (e.g. cardiometabolic and bone density testing) and referral to 29  preventative strategies (e.g. exercise program advice, nutritional advice, psychoeducation).10 After implementation of the clinical pathway, exercise advice was given more frequently in the intervention group compared to the control group (62% vs 11%, p<0.001) and cardiac risk assessment was more frequently performed (61% vs 16%, p<0.001).10 There is a need for more research on the potential of exercise programming embedded in a clinical setting to improve access to services for cancer survivors and in turn improve exercise adoption and adherence.   Finally, beyond the implementation of exercise programs into clinical settings, consideration of an individual’s transition from a highly supervised setting to home-based or community-based exercise is required. A recent qualitative study involving five focus groups interviewed 29 individuals with prostate cancer, the majority whom had continued exercise at a community-based facility.105 The results show that the men believed that supervised exercise from a hospital-based setting provided a safe learning environment and that a structured transition to community-based exercise was important.105 The authors identified the main overarching theme was “from learning to doing” and suggest that having transferable tools (e.g. individualized exercise program), a structured transition plan, sustained peer support and continued monitoring (e.g. check-ups by qualified exercise professionals) may provide the necessary support for a successful transition to a community-based facility.105    2.10 Effectiveness of exercise delivery mode in men with prostate cancer  The majority of exercise interventions demonstrating efficacy in individuals with prostate cancer have been delivered from a supervised setting (e.g. medical or exercise facility) by qualified exercise professionals, using individual or group-based exercise.13-17 Many barriers 30  exist that limit the broader implementation of this type of exercise program and it has been recommended that other delivery methods are evaluated that enable reach and access to exercise and make effective and clinically meaningful change.30,31  2.10.1 Home and distance-based exercise The majority of home and distance-based exercise delivery research has included cancer survivors more generally and has not specifically focused on prostate cancer.43 In individuals with prostate cancer, home-based exercise has commonly been used as a supplement to a supervised exercise program, rather than a stand-alone intervention.13 A systematic review by Keogh et al (2014) compared the effects of home exercise programs (n=5 RCTs) and supervised group exercise (n=7 RCTs) in individuals with prostate cancer.30 For supervised programs, resistance exercise was the primary intervention focus and for home-based programs aerobic exercise was the primary focus.30 The authors concluded that the effects appeared greatest in supervised programs, which can be interpreted as a possible result of the delivery method (i.e. supervised vs home) or of the exercise type (i.e. resistance exercise vs aerobic exercise).30 A recent pilot RCT by Kim et al (2018) evaluated home-based aerobic and weight-bearing exercise intervention in 51 men on ADT and found that a 6-month intervention did not improve bone mineral density (p=0.6 – 0.9).106 Adherence to the weight-bearing exercise, a key physiological stimulus needed improve bone density, was low (65%), which the authors suggest negatively impacted the results.106  The effectiveness of technology supported interventions (e.g. using Wii-Fit) that support home-based exercise in prostate cancer survivors has also been studied. One pilot study by Sajid 31  et al (2019) in 19 men on ADT found that a 6-week home-based walking intervention that included resistance exercise increased the average steps per day by 2720 (95% CI 1313 – 4128) and that this was superior to the technology supported walking intervention that used Wii-Fit (1020 steps/day, 95% CI -474 – 1238).107 A more recent RCT by Villumsen et al (2019) including 46 men on ADT tested a 12-week exergaming intervention that incorporated aerobic and resistance exercise.108 A significant improvement was seen in measures of physical function (6MWT +21.5m, 95% CI 3.2 – 39.9).108 However, no changes were found in power, lean mass, fat mass, quality of life, fatigue, self-reported physical functioning or global health status.108 A prospective single-arm feasibility study by Trinh et al (2018) using a wrist worn activity tracker and web-based incentives (e.g. rewards that included a selection of items and charity donations) evaluated the effect of a 12-week behaviour change intervention that included an incremental walking program in 45 prostate cancer survivors.109 The intervention was effective at reducing sedentary time (-455 mins/week, p=0.005), increasing MVPA (+44 mins/week, p=0.01) and increasing daily steps (+1535 steps/day, p<0.001).109 These results suggest that a well-designed home- or technology-based intervention can be effective at improving aerobic exercise levels short-term.107-109  A recent meta-analysis by Groen et al (2018) on distance-based physical activity interventions in cancer survivors evaluated 5218 participants from 29 RCTs, the majority focusing on increasing moderate-to-vigorous intensity physical activity levels.43 Overall, these distance-based interventions had a small effect on MVPA (SMD 0.21, 95% CI 0.11 – 0.32) and a negligible effect on weekly steps (SMD 0.08, 95% CI -0.24 – 0.39).43 The authors highlight that to better understand the efficacy of home and distance-based interventions, more research that 32  includes individualized exercise prescription and larger sample sizes are required.43 Of note, very few studies have reported on the effect of a distanced-based intervention on participation in resistance exercise. One pilot RCT by Forbes et al (2015) evaluated 95 cancer survivors (28% with prostate cancer) and used a web-based physical activity behaviour change program that included 9 generalized exercise modules.110 Resistance exercise performance changed from 0.9±1.5 to 1.4±2.2 sessions per week over 10 weeks (SMD 0.5, 95% CI -0.02 – 1.0).110  A recent study by Alibhai et al (2019) evaluated a 3-arm phase II RCT that compared supervised personal training, supervised group exercise and home-based exercise supported by a health coach (i.e., exercise physiologist or kinesiologist) over 6-months.111,112 The home-based exercise intervention connected participants and health coaches through a web-based app on a smart phone provided to participants.111,112 A total of 20 of 59 participants were randomized to the home-based exercise and the authors noted that this group focused more on aerobic exercise than the supervised groups.111 Adherence to the intervention appeared greater in the supervised groups (71-75%) compared to the home-based group (50%), however small sample size limits further interpretation of these findings.111 A phase III non-inferiority RCT by Alibhai et al (2019) is currently ongoing and aims to evaluate a home-based delivery model supported by a health-coach against group-based exercise in prostate cancer survivors.113 Overall, these studies indicate that more research is required to better understand the efficacy of technology-supported interventions and how technology can be used to support and enhance exercise delivery methods.106-113  33  2.10.2 Potential of exercise counselling to increase exercise levels in men with prostate cancer  Based on the available literature on most effective delivery approaches and BCT’s to increase exercise adoption and maintenance in cancer survivors, exercise counselling is one intervention approach that may be able to accommodate the complex needs of prostate cancer survivors and overcome the barriers of implementing exercise services into clinical settings.37-51 Exercise counselling is commonly adapted to meet the specific needs of an individual, allowing it to be a more flexible intervention style than supervised exercise interventions used in research studies.44,52 Founded on patient-centred consultation, exercise counselling could enable BCTs to be discussed, tailored, taught and followed over time.44,52 In addition, exercise counselling can be delivered via in-person or distance-based methods (e.g. telephone) and does not require the intensive resource usage (i.e. space, equipment, staffing), which have been previously identified as barriers to exercise service implementation.31 Exercise counselling has previously been successful at achieving behaviour change in individuals with chronic diseases or in people performing unwanted health behaviours (E.g. smoking).53,54 Brief exercise counselling interventions have traditionally been delivered by primary care physicians from medical settings to harness the strength of combining a teachable moment (e.g. cancer diagnosis) and credible resource (e.g. physician).45-50,114 However, primary care physicians believe they lack the knowledge, skills and time to deliver these interventions as part of routine care.45,50,115 One cross-sectional study by Nadler et al (2017) in 120 Canadian oncology care providers examined their knowledge and beliefs about exercise guidelines for cancer survivors and identified barriers and facilitators to exercise discussion.115 Self-reported 34  knowledge on when, how and which patients to refer to exercise programs was reported as poor by 80% of oncology care providers.115 The top four barriers to exercise discussion were limited knowledge on how and where to refer a patient (51%), limited consultation time (43%), not feeling qualified (33%), and safety concerns (25%).115 Oncology care providers believed that the top strategies to promote exercise in oncology practice were patient educational handouts, integration of a qualified professional into the clinical team and education for healthcare professionals.115  Evaluations of patient preferences on exercise counselling suggests a preference for the exercise counselling to be delivered in a face-to-face format by an exercise professional (e.g. exercise physiologist, physiotherapist or kinesiologist) at a hospital or medical location.38,39,42 A cross-sectional study by Jones et al (2002) explored the exercise counseling and programming preferences of 307 breast, prostate, lung and colorectal cancer survivors.39 Results show that 85% of participants preferred to receive face-to-face exercise counselling and 77% preferred it from an exercise specialist who was affiliated with a cancer centre.39 In a more recent systematic review by Wong et al (2018) that evaluated 41 studies, the majority of cancer survivors preferred to receive exercise counselling from a fitness expert associated with a cancer centre or from a physical activity specialist.38 Health practitioners (e.g. specialist nurse, physician or oncologist) were identified as the second most common preference for providing exercise counselling.38   One of the few studies to evaluate exercise counselling as a unique intervention in cancer survivors was a physical therapy-led intervention from within an integrative care setting in the United States by Lopez et al (2019).51 Participants were offered exercise counselling by their physician if they met one of three criteria, namely 1) interested in guidance; 2) not currently 35  meeting exercise guidelines; or 3) uncertain if their current exercise program was appropriate.51 The study enrolled 350 cancer survivors to receive exercise counselling, 43% had breast cancer and 6% had a genitourinary cancer (e.g. prostate cancer), and each visit assessed functional status using physical tests, and administered questionnaires to evaluate mental health (distress, depression, anxiety), pain, and other symptoms (e.g. fatigue, appetite, well-being).51 After the first visit, 31% of participants had at least one follow-up exercise counselling session timed approximately 2-months after the initial visit.51 Pre-post measures show statistically significant changes in all symptom subscales, however, clinically meaningful changes were only found for the global distress score.51 A longitudinal evaluation also showed statistically significant and clinical improvements in fatigue and global health.51 Results of the physical testing for functional status were not reported.51 This study highlights that while exercise counselling can be delivered as a unique intervention to cancer survivors, a more structured delivery protocol may be required within clinical settings.51 Only two previous studies have evaluated the delivery of an exercise counselling intervention to prostate cancer survivors; a mixed methods study by Lemanska et al (2019) that included a multicomponent lifestyle intervention that incorporated an element of exercise counselling, and the 3-arm phase II RCT by Alibhai et al (2019) described above.111,112,116 Lemanska et al (2019) used a community pharmacy team to deliver an intervention to 116 non-metastatic prostate cancer survivors who had completed primary treatment, were inactive and who had a cardiometabolic risk factor.116 At baseline and 3-months, in-person assessments were performed and included physical activity levels (self-report and objectively measured with accelerometers), anthropometric testing and a home support pack (educational DVD, booklet, 36  pedometer, resistance bands) provided by the pharmacy team.116 Pharmacists delivered two telephone support calls that included a lifestyle consultation at 1-week and 6-weeks.116 Attendance was 85% at 3-months and 76% completed accelerometer evaluations at 3- and 6- months.116 Significant improvements were seen in objectively measured MVPA of 34 mins/week (baseline 245+250 mins/week), but significance was not sustained at 6-months.116 At 3-months, BMI decreased by 0.3kg/m2 (p<0001) and weight reduced by 1.0kg (p<0.001).116 These results show that a structured exercise counselling intervention can be efficacious in achieving increases in short-term exercise behaviours, but further intervention modifications are likely required to sustain these changes long-term.111-116  Overall, the literature on exercise counselling suggests it to be a viable intervention that may assist in the adoption and maintenance of exercise behaviours in cancer survivors.38-52,111-116  No previous studies have tested exercise counselling delivered by exercise professionals as an intervention option in individuals with prostate cancer and few studies have explored exercise counselling interventions more broadly across cancer survivors.48,51 As exercise recommendations move beyond the provision of generalized physical activity guidelines and into more specific and individualized exercise prescriptions that manage and overcome treatment side effects, effective methods to deliver these interventions are required.117,118   2.11  PCSC Program Exercise  In British Columbia, a Prostate Cancer Supportive Care (PCSC) Program exists within the Vancouver Coastal Health program offerings to support the needs of men with prostate cancer.55,56 The PCSC Program uses a multidisciplinary team to deliver educational modules and 37  clinical services, focusing on areas such as sexual functioning, mental health, managing ADT side effects, exercise, nutrition and urinary incontinence.55 Appendix A outlines the modules and structure of this program. Exercise education and clinics, provided by an exercise physiologist, are included as part of Module 3: Lifestyle management, and include access to a group-based education session and a one-on-one exercise behaviour change clinic. Individuals with prostate cancer who are living within British Columbia are encouraged to access this program at any point after diagnosis with prostate cancer, and the program aims to deliver comprehensive supportive care across multiple domains as standard of care.55   The first exercise education session was delivered in 2014. To address the intention-behaviour gap related to exercise in individuals with prostate cancer, the PCSC Program introduced an exercise counselling clinic (Exercise Clinic version 1.0 protocol) to its multidisciplinary service offerings in July 2015. Delivered by an exercise physiologist, the Exercise Clinic version 1.0 protocol focused on facilitating exercise behaviour change through one-on-one exercise counselling sessions delivered at baseline, 1-, 3-, 6- and 12-month intervals. The exercise clinic sessions combine motivational interviewing techniques, assessment of physical measures, co-constructed goal setting and individualized exercise prescription. Based on a preliminary effectiveness evaluation of the Exercise Clinic version 1.0 protocol, a revision to the exercise clinic was made. The new offering, Exercise Clinic version 2.0 protocol, was developed by a team of researchers, clinicians and administrators with experience in delivery of exercise programming, including offerings specific to prostate cancer.   The clinic design is founded on research evidence and based on Social Cognitive Theory of behaviour change.119 Social Cognitive Theory describes a framework for understanding how people influence, and are influenced by, their environment, particularly related to the interactions 38  between behaviour, personal factors and environmental influences.119 It outlines that changes in health behaviour can be facilitated by a personal sense of control.119 Viewing self-efficacy as a key component related to individual behaviour change, and one that is influenced by both individual and environmental factors (e.g. barriers and facilitators), the Exercise Clinic version 2.0 protocol includes measures of task self-efficacy, exercise confidence and barriers to exercise at each timepoint.119-121 Additionally, exercise behaviour change has been further supported through the addition of a mandated education session prior to accessing one-on-one exercise counselling, print materials detailing home-based resistance and aerobic exercise programs, exercise recording logs and a follow-up session via telephone at 1-month.   2.12 Summary of literature The evidence clearly demonstrates the efficacy of exercise for individuals with prostate cancer, especially to improve physical function, quality of life and to reduce treatment side effects in controlled research settings.12-23 The challenge now is to translate this evidence into the real world and demonstrate effectiveness of exercise programming for prostate cancer survivors. Due to many factors, prostate cancer survivors have unique needs that need to be considered by exercise programs and interventions designed to improve exercise behaviours.28-34 Currently, prostate cancer survivors in Canada have insufficient aerobic and resistance exercise levels, despite their willingness to engage in exercise.28-29  Strategies to increase exercise behaviours are needed to assist with improving the health of the large number of men living with, and beyond, prostate cancer. Exercise counselling is one possible intervention that could successfully integrate key BCTs into supportive care 39  programming provided within a clinical setting to improve exercise behaviours of prostate cancer survivors in British Columbia.38,55 Knowledge of the feasibility of delivering the Exercise Clinic version 2.0 protocol within the PCSC program, and the effect observed, will further the understanding of the role of a specific exercise counselling protocol, delivered within a real-world clinical setting, on capacity for behaviour change in prostate cancer survivors.  2.13 Purpose  The purpose of this study is to evaluate the feasibility and preliminary effect of an exercise counselling clinic at increasing weekly aerobic and resistance exercise behaviours in individuals with prostate cancer.  2.14 Objectives & Hypotheses Primary Aim:     To evaluate the feasibility of delivering the PCSC Program Exercise Clinic version 2.0 protocol that is specific to men with prostate cancer and delivered from a clinical setting.  We hypothesize that the Exercise Clinic version 2.0 protocol will be feasible to deliver by the PCSC Program, as measured by session attendance (>60% at each timepoint, based on Exercise Clinic version 1.0 protocol attendance), session timing (75% within stated timing protocol), attrition (<30% at 3-months, based on Exercise Clinic version 1.0 protocol attrition), intervention delivery fidelity (>75% of each exercise clinic delivered as planned) and intervention component fidelity (>75% of each intervention component delivered across all sessions). 40  Secondary Aim:    To evaluate the preliminary effect of the PCSC Program Exercise Clinic version 2.0 protocol at improving exercise behaviours of individuals with prostate cancer over 3-months, and to compare to the effect reported in the PCSC Program Exercise Clinic Version 1.0 protocol. We hypothesize that the Exercise Clinic version 2.0 protocol will improve exercise behaviours of prostate cancer survivors at 3-months, as measured by self-reported moderate-to-vigorous aerobic exercise levels and number of resistance exercise sessions during an average week, and that improvements will show a larger effect size when compared the same measures from the Exercise Clinic version 1.0 protocol.  Tertiary Aim:    To evaluate the association between task self-efficacy (specific to moderate, vigorous and moderate-to-vigorous exercise) and aerobic exercise levels (moderate, vigorous and moderate-to-vigorous minutes/week) in individuals with prostate cancer who attended the PCSC Program Exercise Clinic and received the version 2.0 protocol.   We hypothesize the following: a) Higher task self-efficacy at Exercise Clinic Session 1 will be correlated with higher exercise levels at Exercise Clinic Session 1. b) A larger change in task self-efficacy will be associated with a larger change in aerobic exercise levels in prostate cancer survivors at Exercise Clinic Session 3, as measured by 41  self-reported weekly aerobic exercise levels and aggregate task self-efficacy scores for moderate, vigorous and moderate-to-vigorous intensity aerobic exercise. Exploratory Aim:    To evaluate the change from Exercise Clinic Session 1 to Exercise Clinic Session 3 of anthropometric and physical measurements taken in the Exercise Clinic version 2.0 protocol. We hypothesize that the Exercise Clinic version 2.0 protocol will show improvements at Exercise Clinic Session 3 when compared to Exercise Clinic Session 1, of a small to moderate effect, in blood pressure, resting heart rate, BMI, waist circumference, fatigue, short physical performance battery (SPPB), handgrip strength and exercise enjoyment.   42  Chapter 3: Methods 3.1 Study design This study was a retrospective chart review that reviewed medical records from the Vancouver PCSC Program Exercise Clinic version 2.0 protocol, which includes the delivery of group education and individualized exercise counselling over a 12-month period. The PCSC Program is a multidisciplinary supportive care program specific to individuals with prostate cancer that includes modules in six areas, as shown in Appendix A.55 Module 3 “lifestyle management”, contains a nutrition component delivered by a Registered Dietitian and an exercise component (Exercise Clinic version 2.0 protocol), delivered by a clinical exercise physiologist. Participants of the PCSC program are able to choose the modules they participate in. This study reviewed charts specifically of participants who participated in the Exercise Clinic version 2.0 protocol which was instituted starting on June 11, 2018 and the prior version 1.0 protocol was discontinued at that time for all new participants. Approval for this study was obtained by the institutional clinical review board at the University of British Columbia and the Vancouver Coastal Health Research Institute (VCHRI) operational approval. This study was performed for the purposes of quality assurance and to enhance future program delivery.  3.2 Study Participants Study participants were recruited from the PCSC Program using a consecutive sampling strategy. Participant referral to the PCSC Program is by Urologist, primary care physician (e.g., General Practitioner) or through self-referral. PCSC Program inclusion criteria specifies that participants must: be male and over 19 years of age; have a diagnosis of prostate cancer at any 43  stage (including those on active surveillance and those with metastatic prostate cancer); and be willing to attend the Vancouver PCSC Program location for sessions. All PCSC Program participants are eligible to attend the Exercise Clinic version 2.0 protocol. To be included in this evaluation, participants must have participated in the Exercise Clinic using the version 2.0 protocol and attended Exercise Clinic Session 1 prior to 10 January 2019. Cut-off dates for data inclusion were applied to ensure that any participant who had attended Exercise Clinic Session 1 were given adequate time to attend Exercise Clinic Session 3 (i.e., 3-months). Participants were excluded from this study if they did not meet the study inclusion criteria or if they had been instructed by their doctor not to exercise.   3.3 Exercise Clinic version 2.0 protocol The participant pathway and protocol timeline for the Exercise Clinic version 2.0 protocol is shown in Figure 1. All sessions are conducted by a clinical exercise physiologist certified by the Canadian Society for Exercise Physiology (CSEP-CEP).   3.3.1 Education session  The education session is the starting point of the Exercise Clinic version 2.0 protocol. Participants are required to attend a group-based 90-minute exercise education session prior to attending the one-on-one exercise clinic sessions. The mandatory education session is specific to prostate cancer and presents research evidence on four main areas: 1) benefits of exercise, 2) exercise recommendations, 3) using exercise to manage and overcome treatment side effects (e.g., fatigue, muscle loss), and 4) how to get started with exercise. As part of the education 44  session, a group-based question and answer period is scheduled for the final 15 minutes and participants are also able to speak with the clinical exercise physiologist individually at the completion of the session. The modified Godin Leisure Time Exercise Questionnaire (GLTEQ) is administered during the session to evaluate self-reported exercise levels within a typical week during the past month (Appendix B).122,123 Based on the moderate-to-vigorous aerobic exercise levels self-reported on the GLTEQ, participants are stratified into one of three activity categories (0-49, 50-99, 100-150+ mins/week of MVPA) and given an aerobic home exercise program (Appendix C). A recording log is provided to participants and they are instructed to complete it and bring it to Exercise Clinic Session 1 (Appendix D).  3.3.2 Exercise Clinic Sessions  After attending the education session, participants are eligible to be booked into the exercise clinic. As outlined in Figure 1, the Exercise Clinic version 2.0 protocol includes four face-to-face sessions and one telephone follow-up session over 12-months. All sessions are scheduled with the participant by the PCSC Medical Office Assistant (MOA). This study evaluated participant’s results up to the Exercise Clinic Session 3 (i.e., 3-month follow-up). The outcome and evaluation tools used in the Exercise Clinic are outlined in Table 1.   Setting:   The Exercise Clinic version 2.0 protocol is administered from a small clinical room in a specialist medical building, the Gordon and Leslie Diamond Health Care Centre, and during the evaluation period was offered on two half-days per week. The room is located on the same floor as the Vancouver Prostate Centre Urology clinic. The clinical room contains a desk, computer, 45  desktop printer, couch and chair and the exercise clinic equipment (blood pressure sphygmomanometer, body weight scale, height stadiometer, cloth tape measure, grip strength dynamometer, two five-pound dumbbells and two ten-pound dumbbells). The clinical room is shared by multiple healthcare professionals, each using it on different days. Exercise Clinic Session 1: Exercise Clinic Session 1 is 75 minutes in duration. Pre-clinic questionnaires are given to the participant by the Medical Office Assistant (MOA) approximately 15-minutes prior to their session start time and questionnaires are completed by the participant independently (Table 1). The pre-clinic questionnaires administered during Exercise Clinic Session 1 are a personal history questionnaire (Appendix E), Get Active Questionnaire to inform pre-exercise safety screening and clearance (Appendix F), Modified Godin Leisure Time Exercise Questionnaire (GLTEQ) to inform current exercise levels (Appendix B), Task self-efficacy, barriers and exercise enjoyment questionnaire (Appendix G), FACIT-Fatigue questionnaire (Appendix H), and a visual analogue scale fatigue questionnaire (VAS-Fatigue) (Appendix H)122-132 The Exercise Clinic Session 1 is structured to include: 1) a verbal review of pre-clinic questionnaires with participant; 2) exercise risk stratification by the clinical exercise physiologist, based on the review of the Get Active Questionnaire; 3) verbal delivery of readiness for change questionnaire; 4) recording of basic physical measures by the clinical exercise physiologist (Table 1); 5) verbal delivery of exercise prescription; and 6) verbal delivery of one on one exercise counselling, including goal setting and action planning (i.e. a step-by-step plan that details the actions required to achieve a goal). Data is recorded on a data collection sheet (Appendix I). Based on exercise counselling literature, the exercise clinic sessions 46  incorporate a patient-centred approach, which involve the patient and their needs being a central component that guides the exercise counselling session and treatment plan, and also includes evidence-based information and co-constructed goal setting.44-54 A written aerobic and/or resistance exercise prescription is provided to participants to address the specific needs that the individual and the clinical exercise physiologist identified. The exercise prescription can be completed at home or at an exercise facility the individual has access to. To support engagement in an aerobic exercise prescription, a FITT-VP (Frequency, Intensity, Time, Type, Volume, Progression) exercise prescription is written down and given to the participant. To support engagement in resistance exercise, a structured, home-based resistance exercise program has been developed for the Exercise Clinic version 2.0 protocol that uses print materials and three pre-designed options for the appropriate resistance, namely: body weight, dumbbell or band exercises. The program volume (sets/reps/load) can then be further tailored to each individual’s needs (Appendix J) and exercises added and removed as deemed clinically necessary. At completion of the Exercise Clinic Session 1, the participant receives an overview and explanation of the tests performed (Appendix K), a copy of their results, goals and exercise prescription (printed copy of page 3 and 4 of data collection sheet – Appendix I) and printed copies of any resistance training programs that were prescribed. Once the participant leaves, the clinical exercise physiologist has up to 15-minutes to complete any charting requirements prior to seeing the next participant. Exercise Clinic Session 2: Exercise Clinic Session 2 is a 15-minute telephone call administered approximately 30-days after Exercise Clinic Session 1. The intent of this participant contact is to gauge if the 47  participant is on-track to achieve their short-term goals. The clinical exercise physiologist attempts to call the participant up to 3 times during the scheduled session time. The clinical exercise physiologist uses the “1-month telephone data sheet” (Appendix L) as a guide during the call, verbally administers the GLTEQ, asks the participant about any exercise barriers that currently exist and also about their progress towards the goals that were set in the Exercise Clinic Session 1. As required, the goals and exercise prescription are adjusted to address the current needs of the participant.  Exercise Clinic Sessions 3, 4, 5:   The Exercise Clinic Sessions 3, 4 and 5 are all in-person follow-ups, 45 minutes in duration, with questionnaires administered as outlined in Table 1. Pre-clinic questionnaires are given to the participant by the MOA approximately 15-minutes prior to their session start time and questionnaires are completed by the participant independently. In-clinic questionnaires and data collection are administered verbally by the clinical exercise physiologist and data is recorded on a data collection sheet (Appendix I). The follow-up exercise clinic sessions are structured similarly to Exercise Clinic Session 1, with the exception of the medical history taking and pre-exercise screening, which are not performed in Exercise Clinic Sessions 3, 4 and 5. The follow-up exercise clinic sessions additionally review the participant’s progress, compare the results with those from the prior session, evaluate self-directed exercise behaviours since the past session and contextualize results based on current behaviours and treatments.  Exercise clinic session bookings:   The MOA is responsible for all session bookings, including session reminders, follow-up bookings and rescheduling missed sessions. All sessions are scheduled using an electronic 48  medical records booking system. A reminder email or telephone call, based on stated participant preference, occurs approximately 3-days prior to each session. Missed sessions are followed up by the MOA and the participant is allowed to re-reschedule within a reasonable timeframe. After two unsuccessful attempts to contact a participant, the MOA marks the participant as unresponsive to follow-up and they are considered to have dropped out of the exercise clinic unless they initiate contact with the program to resume sessions Discharge from exercise clinic:  Participants are able to stop participating in the Exercise Clinic version 2.0 protocol at any timepoint, however, they are encouraged to attend all sessions. At the completion of the 12-month follow-up (i.e., Exercise Clinic Session 5), participants are discharged from the Exercise Clinic version 2.0 protocol and a brief discharge letter is added to their PCSC Program electronic medical records, accessible by their Urologist. For participants who require additional support after this period, they are referred to the HealthLink BC Physical Activity Service for Cancer, a telephone support service that provides access to a clinical exercise physiologist and can be accessed free of charge by residents of BC. If a participant who has previously completed the exercise clinic (version 1.0 or 2.0 protocols) develops a recurrence or progression of their prostate cancer that requires a treatment they have not previously received (e.g., ADT or chemotherapy), they are able to access one additional exercise clinic session with the clinical exercise physiologist to assist with understanding exercise safety during and after the treatment they will be receiving. Additionally, a video recording of the exercise education session is accessible from the PCSC Program webpage at all times and interested participants are directed to this resource as required. 49  Exercise clinic Behaviour Change Techniques: Exercise Clinic version 2.0 protocol includes many BCTs and these were implemented across the protocol structure. A summary of the BCTs was performed by the PCSC Clinical Exercise Lead, using the BCT CALO-RE taxonomy and are shown in Appendix M.96 This taxonomy was chosen as it has been designed to specifically evaluate BCT of physical activity interventions.96 The intervention component list and the Exercise Clinic version 2.0 protocol description were used to identify BCTs utilized in Exercise Clinic version 2.0 protocol at each timepoint. BCTs that were not included in the Exercise Clinic version 2.0 protocol design are marked accordingly.  3.4 Outcome measures   The outcome measurements are administered and recorded at each session, as outlined in Table 1. Pre-clinic measures are completed independently by the participant and during clinic measures are administered by the clinical exercise physiologist as part of their exercise counselling session.   3.4.1 Primary outcome measures: Feasibility  Feasibility was measured across five separate components: 1) session attendance; 2) protocol attrition; 3) session timing; 4) intervention delivery fidelity; and 5) intervention component fidelity. The a priori definitions for feasibility are outlined in Table 2.   Session attendance:   Attendance across each session is recorded by the MOA using the electronic medical 50  records administrative system, with participants marked as “arrived” or “not arrived” (e.g., cancelled or no show) for all session bookings. All Exercise Clinic version 2.0 protocol sessions that were within the data collection timeframe are included in the attendance reporting. For the education sessions, attendance is defined as the number of participants that attended the session reported against the number that booked into the session. For Exercise Clinic  Sessions 1, 2 and 3, attendance is defined as the total number of participants that attended the session, reported against the total number of participants who had attended an education session.  Attrition:  Attrition was defined as the percent of participants who dropped out of the Exercise Clinic version 2.0 protocol and was measured at exercise clinic sessions 1, 2 and 3. Attrition was calculated using the attendance data. Specifically, attrition at the Exercise Clinic session 1, 2 and 3 was calculated from the number of participants who attended the education session who did not attend an exercise clinic session at any timepoint and did not book into any further sessions (i.e. they withdrew or dropped out of the Exercise Clinic version 2.0 protocol). If a session was missed but a future clinic session had been booked, a missed session was recorded, and this was not counted towards attrition.  Session timing:  The protocol outlining timing of each session is shown in Figure 1. The date of each participant’s session was recorded and the days between sessions were calculated to determine session timing. Participants can attend an exercise education session at any point after joining the PCSC program. The MOA is responsible for all session bookings and the protocol requires 51  sessions to occur within the listed timeframe +/- 20%. For this study, appropriate timing was defined as follows: Exercise Clinic Session 1 within 36 days of the education session (30-days +20%); Exercise Clinic Session 2 within 24 to 36 days after Exercise Clinic Session 1 (30 days +/- 20%); and Exercise Clinic Session 3 within 73 – 109 days after Exercise Clinic Session 1 (91 days +/- 20%).  Intervention delivery fidelity: Using the data recording sheet (Appendix I), 39 items were identified as major components of the delivery of the exercise clinic sessions and are listed in Table 3. The 39 items reflect data that was recorded on the data sheet by the clinical exercise physiologist, including pre-clinic questionnaire results, goal setting, physical measures and exercise recommendations. The evaluation of each exercise clinic session for inclusion of all 39 components is defined as intervention delivery fidelity. To achieve 100% intervention delivery fidelity, data would need to be collected for all 39 items. If an item was left blank (i.e., missing) it was marked on the data recording form as “blank” to identify that it was not filled out. To evaluate the intervention delivery fidelity, the data from Exercise Clinic Sessions 1 and 3 were used. Each session was evaluated across the 39 intervention components to identify the number of missing data points. Intervention delivery fidelity was calculated using the average number of completed intervention components for each timepoint against the total number of intervention components (n=39). The higher the completion score (0 to 39), the greater the fidelity of delivery.  Intervention component fidelity:  Each of the 39 intervention components were also evaluated separately to identify the intervention component fidelity of each item. The intervention component fidelity was calculated 52  using the total number of sessions that recorded an individual component divided by the total number of sessions. The intervention component fidelity score evaluates all of the 39 components separately to assist in identifying fidelity issues with an individual component, which could impact program delivery.   3.4.2 Secondary outcome measures: Change in self-reported exercise behaviours The change in self-reported exercise behaviours, specifically weekly levels of moderate-to-vigorous aerobic exercise and resistance exercise, is evaluated using results of the modified Godin Leisure Time Exercise Questionnaire (GLTEQ) (Appendix B).122,123 This questionnaire assesses self-reported leisure-time physical activity levels, divided into light, moderate and strenuous aerobic exercise intensities.122 The GLTEQ asks about frequency at each exercise intensity within a typical 7-day period over the past month.122 This questionnaire specifies that activity should only be counted if it lasted for 10-minutes or longer and if it was done during free time (i.e. do not include occupational activity or housework).122 The questionnaire has been modified from its original form to include a duration column for each item and an additional row that captures resistance exercise, similar to previous studies.123 The modified version has been used in previous studies with prostate cancer patients to quantify weekly moderate-to-vigorous aerobic exercise and resistance exercise sessions.123 Calculations of average self-reported weekly aerobic exercise can be obtained for each exercise intensity by multiplying frequency and duration, to obtain a total minutes per week.28,123 Weekly resistance exercise volume is calculated using self-reported weekly frequency of resistance exercise.123 To reduce commonly experienced measurement error associated with the misreporting of exercise intensity, the 53  clinical exercise physiologist discusses results of the GLTEQ during each exercise clinic session.123 If the questionnaire had been filled out incorrectly (e.g. not for a typical week in the past month or incorrect exercise intensity classification), the participant completes corrections to the data sheet during their session with the exercise physiologist and the corrected version is used by the clinical exercise physiologist to guide the session and for data collection purposes.  Aerobic and resistance exercise levels of the Exercise Clinic version 2.0 protocol were evaluated at three timepoints: 1) education session; 2) Exercise Clinic Session 1; and 3) Exercise Clinic Session 3. Exercise Clinic Session 2 (via telephone) was excluded from this evaluation as the questionnaire was administered verbally by the exercise physiologist. Additionally, the change in self-reported exercise levels from the first session to the 3-month session was compared between Exercise Clinic version 2.0 protocol and the first iteration of this exercise clinic, Exercise Clinic version 1.0 protocol, which operated from July 2015 to July 2018. The first session in the Exercise Clinic version 2.0 protocol is the education session. The education session was not a mandatory component of exercise clinic 1.0, so in exercise clinic 1.0 the first session is the baseline exercise clinic session. The measurements in each clinic were administered and recorded using the modified GLTEQ.  3.4.3 Tertiary outcome measures: Task self-efficacy and exercise levels  Task self-efficacy is evaluated using the Health Action Process Approach (HAPA) measure, which rates self-efficacy for both moderate and vigorous levels of aerobic exercise.124 This approach has been previously used in similar physical activity research.124-126,133-135 The 10-item questionnaire requires participants to rate their confidence between 1 (not confident at all) and 7 (completely confident) in performing moderate-intensity or vigorous-intensity physical 54  activity without stopping for 10-, 20-, 30-, 45- and 60-minute intervals. An individual aggregate score (out of 7) can be calculated for aerobic exercise of moderate-intensity, vigorous-intensity and moderate-to-vigorous intensity. Task self-efficacy was evaluated specifically for aerobic exercise at Exercise Clinic Session 1 and 3. Additionally, change in task self-efficacy was calculated between these timepoints.  3.4.4 Exploratory outcome measures The following measures were evaluated for exploratory purposes and were measured at Exercise Clinic Sessions 1 and 3.  FACIT-Fatigue:  The FACIT-Fatigue scale was administered to evaluate fatigue (Appendix H). The FACIT-Fatigue scale is a 13-item questionnaire that evaluates cancer-related fatigue.127,128 Each item is measured on a 0 – 4 scale. The FACIT-Fatigue scoring system was used to convert the 13-items to a fatigue score out of 52 points.127 The lower the total FACIT-fatigue score, the higher and more clinically significant the fatigue is believed to be. Scores of 0 to 34 have been validated to indicate clinically significant fatigue.127,128 The meaningful clinically important difference (MCID) is classified as a change of 3-points in the total fatigue score.127 This measurement tool has shown good internal consistency (alpha = 0.86 – 0.87) and validity (0.73 – 0.84).127 VAS-Fatigue (average and maximum):   The Visual Analogue Scale (VAS) specific to fatigue is a single item scale from the 55  Edmonton Symptom Assessment Scale and assesses global fatigue on a self-report scale from 0 (no fatigue) to 10 (maximal fatigue) (Appendix H).129 Participants are instructed to circle the number on the line that represents their current average and maximum fatigue levels, with only whole numbers being recorded. Scores of 1-3 represent mild fatigue, 4-6 moderate fatigue and 7-10 severe fatigue.129 The score reported was the number that had been circled. Group mean scores for a person’s average fatigue experienced were reported in this evaluation. Short Physical Performance Battery:  The 3-item SPPB test evaluates a person’s physical function using three tests:  1) 5-repetition sit to stand test, that measures the time taken to perform five complete sit-to-stand repetitions (seconds). Scoring: 4-points for <11.19 seconds, 3 points for 11.2 – 11.69 seconds, 2-points for 13.7 – 16.69 seconds, 1 point for >16.7 seconds;  2) Tandem balance test, that measures a participant’s ability to balance for 10-seconds in three different positions – level 1 - feet together, level 2 - feet semi-tandem, level 3 - feet tandem. Scoring: 1-point for level 1, an additional 1-point for successful completion of level 2, an additional 2 points for successful completion of level 3, and if 3.0 – 9.99 seconds is achieved on level 3 only 1 additional point is allocated.  3) Normal gait speed test over 3-metres. Scoring: 4-points <3.62 seconds, 3 points 2.62 – 4.65 seconds, 2 points 4.66 – 6.52 seconds, 1 point > 6.52 seconds.  A score out of four for each section is given, with an SPPB score of 12 indicating maximum results and greater function. For the SPPB, a MCID of 1.0 has been identified in community-dwelling older adults, with excellent test-retest reliability (ICC = 0.81 to 0.91) and adequate internal consistency (Cronbach’s alphas = 0.63 to 0.66).136-138 56  Handgrip Strength:  A JAMAR digital handgrip dynamometer was used to measure maximum isometric strength of the hand and forearm muscles of both the left and right sides and is recommended as a valid strength test for prostate cancer suvivors.139-142 Participants stand with their arm abducted to ~30-degrees and are instructed to squeeze the dynamometer maximally. Two trials are given on each side and the maximum value (kg’s) is recorded for left and right. Total grip strength (left plus right scores) were calculated from the recorded values, with higher scores indicating greater grip strength. The MCID for grip strength is considered to be a change of 1.75 kg or greater.141 Excellent inter-rater reliability (r=0.98) and good to excellent test-retest reproducibility (r>0.80) has been shown in previous studies.142 Body Mass Index:  Height is measured at Exercise Clinic Session 1 with a stadiometer and body weight is measured at each exercise clinic session with a digital scale. BMI is calculated using the formula BMI = weight (kg) / (height (m)2) and classified as underweight, normal, overweight or obese class I-III using the standards developed by the World Health Organization.143 Exercise enjoyment:  Exercise enjoyment was measured using a 1 to 5 Likert rating system for the questions “I enjoy engaging in regular physical activity ….”, where 1 equals “disagree” and 5 equals “agree” that has been previously used in breast cancer research.144,145 This item was administered with the task self-efficacy questionnaire. Average scores were reported, with higher scores indicating greater exercise enjoyment. A previous study in breast cancer survivors that used this measure 57  found moderate and significant associations (Person correlation coefficient) between higher exercise enjoyment and higher energy expenditure (r=0.60, p=0.02).145  3.5 Ethics and Informed Consent Ethical approval was obtained for this study through the University of British Columbia Clinical Research Ethics Board. Due to the nature of the retrospective chart review, informed consent was not required to review the de-identified data. In addition, Vancouver Coastal Health Research Institute (VCHRI) operational approval was obtained prior to starting this study.   3.6 Statistical Analysis 3.6.1 Sample size A minimum sample size of 24 to 30 individuals is recommended to assess the primary aim of feasibility.146-148 As per published recommendations, studies that have feasibility outcomes as the primary aim should use caution when reporting more than descriptive statistics as they are often underpowered.149-154 For this reason, our evaluation only used descriptive statistics and reported effect size and 95% confidence intervals (CIs). Effects sizes are calculated independent of sample size and are recommended for use when evaluating an underpowered outcome in a small sample.155,156   3.6.2 Analysis Analysis was performed using IBM SPSS Version 24 (IBM Corp, Armonk, NY). Descriptive statistics were used at baseline to characterize the participants specific to age, marital 58  status, ethnicity, highest education level, employment status, treatment status, treatments received, comorbid conditions, BMI and exercise levels. Primary aim:    To analyze feasibility, descriptive statistics were used to calculate percentages of attendance, attrition, session timing, intervention delivery fidelity and intervention component fidelity. Feasibility was defined a priori, as shown in Table 2. Attendance and attrition were based on data extracted from the Exercise Clinic version 1.0 protocol evaluation, shown in Table 2, with a goal to improve on these results. Protocol timing and fidelity measures were based on decisions reflecting pragmatic clinical program delivery expectations.157-159 Secondary aim:    To analyze change in exercise behaviours (weekly aerobic exercise and resistance exercise sessions) from the education session to Exercise Clinic Session 3 (3-months) in the exercise Clinic version 2.0 protocol, the total change, standard deviation (SD), 95% CI and effect size was calculated. To evaluate the difference between Exercise Clinic version 1.0 and 2.0 protocols, the total change in exercise levels from the first exercise session and the 3-month sessions were evaluated. In version 1.0, this was the baseline exercise clinic and the 3-month exercise clinic; In version 2.0, this was the education session and Exercise Clinic Session 3. The total change, standard deviation, effect size and 95% CI of the effect size were calculated. Due to differences in sample sizes, the Hedges G correction factor was applied when calculating the effect size, which accommodates for the sample size differences by using a correction factor.160  Tertiary aim:    To analyze if an association exists between task self-efficacy scores and aerobic exercise 59  levels, a Spearman rank-order correlation test was used as it can assess the strength and direction of association between the two variables. Two separate analyses were performed: 1) Baseline task self-efficacy score (Exercise Clinic Session 1) against baseline aerobic exercise level (for moderate intensity, vigorous intensity and moderate-to-vigorous intensity aerobic exercise) and 2) change in task self-efficacy score from Exercise Clinic Session 1 to Session 3 against the change in aerobic exercise level (for moderate intensity, vigorous intensity and moderate-to-vigorous intensity aerobic exercise). The Spearman rank-order correlation test was chosen as it is a non-parametric test that is used when the assumptions necessary for performing the Pearson product-moment correlation have not been met.  Exploratory Analysis:    To analyze the change in anthropometric and physical function variables from Exercise Clinic Session 1 to Exercise Clinic Session 3 (3-months) in the Exercise Clinic version 2.0 protocol, the mean change, SD, effect size and 95% CI of the effect size were calculated for resting blood pressure (diastolic and systolic), resting heart rate, BMI, waist circumference, handgrip strength, SBBP (total score and score of each individual item), fatigue (FACIT-fatigue and VAS-fatigue) and exercise enjoyment.       60  3.7 Tables and Figures    Figure 1. PCSC Exercise Clinic version 2.0 protocol timeline ß  30-days à Education Session Exercise Clinic 1  (in-person) Exercise Clinic 3 (in-person) Exercise Clinic 4 (in-person) Exercise Clinic 5 (in-person) Exercise Clinic 2 (telephone) ß  30-days à 1-MONTH 3-MONTHS 6-MONTHS 12-MONTHS ß--------------------------  91-days -------------------à BASELINECLINIC 61  Table 1. Exercise Clinic version 2.0 protocol: Evaluation Pathway Questionnaire / Measure Education session Exercise Clinic Session 1 Exercise Clinic Session 2 (telephone) Exercise Clinic Session 3 Personal history questionnaire  x (Pre)   Get Active Questionnaire (GAQ)  x (Pre)   Modified Godin Leisure-Time Questionnaire (GLTEQ) x x (Pre) x (C) x (Pre) Task self-efficacy, barriers & enjoyment questionnaire  x (Pre)  x (Pre) Fatigue: FACIT-Fatigue questionnaire & Visual Analogue Scale (VAS) - Fatigue       x (Pre)  x (Pre) Side effects of treatments (Assessment sheet)  x (C)  x (C) Stage of change (Assessment sheet)  x (C)  x (C) Main barriers and facilitators to exercise (Assessment sheet)  x (C) x (C) x (C) Physical measures: height, weight, BMI, resting heart rate, resting blood pressure, Short Physical Performance Battery (SPPB), grip strength.  x (C)  x (C) Goal setting (Assessment sheet)  x (C) x (C) x (C) Aerobic exercise program x x (C) Review x (C)  Review x (C) Review Resistance exercise program  x (C) x (C)  Review x (C) Review   Note: Pre = administered immediately prior to session via questionnaire; C = Administered during session by clinical exercise physiologist        62  Table 2: A priori feasibility definitions of Exercise Clinic version 2.0 protocol Measurement Feasibility criteria  Notes Exercise clinic 1.0 result Attendance 60% Education session = number attended / number booked x 100 Exercise clinic = number attended / education session attendance x 100 Feasibility reported at each timepoint. 56% at  3-months Attrition 30% Attrition reported at each time-point. 33.3% at  3-months Protocol timing  (+/- 20%) 75% Evaluated for all exercise clinic sessions, with the education session as timepoint zero. Unknown Intervention delivery fidelity 75% Evaluated at exercise clinic #1 and #3 using the 39-data points outlined in Table 3. Unknown Intervention component fidelity 75% Evaluated at exercise clinic #1 and #3 using the 39 data-points outlined in Table 3. Unknown          63  Table 3. Exercise Clinic version 2.0 protocol: Intervention fidelity components  Items identified from data collection sheet as critical to intervention delivery 1 Appointment date 14 Current exercise (any) 27 Meets aerobic guidelines 2 Type of appointment  15 Systolic blood pressure 28 Resistance sessions/week 3 Attended with partner (Y/N) 16 Diastolic blood pressure 29 Meets resistance guidelines 4 Treatment status 17 Resting heart rate 30 FACIT-Fatigue score  (from questionnaire) 5 Treatment/s received 18 Body weight 31 VAS score / 10  (from questionnaire) 6 Treatment side effects 19 Height 32 Grip strength  7 Other medical history 20 Body Mass Index 33 Exercise goal setting  (1 or more listed) 8 Risk stratification 21 Waist circumference 34 Physical activity recommendation  (1 or more listed) 9 Exercise considerations & restrictions 22 SPPB (total / 12) 35 Resistance training program (DB, BW, Band) 10 Stage of change (SOC) (Y/N) 23 SPPB 5-rep chair stand (/4) 36 Personal History Questionnaire 11 SOC category 24 SPPB Balance (/4) 37 Get Active Questionnaire 12 Exercise barriers  (1 or more listed) 25 SPPB Gait speed (/4) 38 Modified GLTEQ Questionnaire 13 Exercise facilitators  (1 or more listed) 26 MVPA mins/week 39 Task self-efficacy questionnaire   64  Chapter 4: Results 4.1 Participants The flow of participants through the Exercise Clinic version 2.0 protocol participant flow is shown in Figure 2. Overall, 38 participants attended the education module and 34 attended Exercise Clinic Session 1 within the study timeframe. The baseline participant demographic and treatment-related characteristics recorded during Exercise Clinic Session 1 are summarized in Table 4. Mean participant age was 68.3±2.6 years. The majority of participants were Caucasian (n=28, 82.4%), married or in a common law relationship (82.4%, n=28), retired (64.7%, n=22) and had attained some level of post-secondary education (92.8%, n=31). On average, participants were 24.2±35.6 months since diagnosis and had joined the PCSC Program 10.4±14.9 months prior to attending the exercise module. Specific to treatment characteristics, 20.6% (n=7) of participants were receiving current treatments, 26.5% (n=9) had recently completed treatment (within 3-months prior to attending), 32.4% (n=11) of participants had finished treatments greater than 3-months prior and 17.6% (n=6) of participants had not received any treatment. Surgery was the most commonly administered treatment, received by 73.5% (n=25) of participants, followed by Androgen Deprivation Therapy (35.3%, n=12) and external beam radiation therapy (26.5%, n=8). The presence of one or more treatment-related side effects was identified by 96.4% (n=27) of participants who had received treatment at any time. The most common side effects experienced were urinary incontinence (63.0%, n=17), fatigue (63.0%, n=17) and erectile dysfunction (51.9%, n=14). The self-reported level of fatigue was clinically significant in 29.4% of participants (n=10). Additionally, the majority of participants (70.6%) identified having at least one comorbidity (e.g., hypertension, osteoarthritis, Type 2 diabetes, Parkinson’s Disease, 65  cardiovascular disease), a previous cancer or a current musculoskeletal issue (e.g. knee pain, hernia).  As shown in Table 4, at the exercise education session, only 11.8% of participants (n=4) were meeting the current exercise guidelines for public health of 150 minutes of moderate-to-vigorous aerobic exercise and two resistance training sessions weekly. The majority of participants (47.1%, n=16) met no exercise guidelines, 29.4% (n=10) met aerobic exercise guidelines and 26.5% (n=9) met resistance exercise guidelines. The self-identified stage of change of participants at Exercise Clinic Session 1 were as follows: in preparation (20.6%, n=7); action (29.4%, n=10); and maintenance (50%, n=17). No participants identified as being in the contemplation or pre-contemplation stages of change.  4.2 Attendance             Figure 2 describes participant flow at each timepoint. Between 11 June 2018 and 10 January 2019, seven exercise education sessions were delivered at monthly intervals and a total of 55 individuals signed up to attend the sessions. Of these individuals, 38 attended the education session (69.1%). Two participants delayed starting the exercise clinic after attending the education session and were excluded from further data analysis due to being outside of our data collection range when beginning Exercise Clinic Session 1. Of those who attended the education sessions who were included in further analysis (n = 36), 94.4% (n=34) continued on to Exercise Clinic Session 1, 80.6% (n=29) attended Exercise Clinic Session 2 (i.e.,1-month telephone consultation) and 80.6% (n=29) attended Exercise Clinic Session 3 (i.e. 3-months follow-up). Based on the a priori targets, attendance feasibility (>60%) was achieved at all timepoints. These 66  results are summarized in Table 5 and comparisons between attendance and attrition results are depicted in Figure 3.   4.3 Attrition  Based on the enrollment of 36 participants, at Exercise Clinic Session 1 attrition was 5.6% (n=2) and at Exercise Clinic Session 2 attrition was 11.1% (n = 4). An additional 3 participants missed Exercise Clinic Session 2 but still attended Exercise Clinic Session 3 and were not counted towards attrition. At Exercise Clinic Session 3, attrition was 19.4% (n = 7). Based on the a priori targets, attrition feasibility (<30%) was met at all timepoints. These results are summarized in Table 5 and comparisons between attendance and attrition results are depicted in Figure 3.  4.4 Session Timing Table 5 summarizes the session timing results. On average, participants attended Exercise Clinic Session 1 19.0±18 days after attending the group education session, which was within the a priori target of <36 days. Exercise Clinic Session 2 occurred on average 36.4±7 days after Exercise Clinic Session 1, which was not within the a priori target of 24 – 36 days. For exercise Clinic Session 3, participants attended an average of 98.2±21 days after Exercise Clinic Session 1, which was within the a priori target of 73 – 109 days after Exercise Clinic Session 1. The a priori feasibility target of 75% of individuals who attended their session within the timing protocol was met for Exercise Clinic Session 1 and 3 (82.4% and 89.7%, respectively) (Figure 4). Exercise Clinic Session 2 did not meet the a priori feasibility target, with only 65.5% of participants attending within the delivery timeframe.  67  The distribution of data at each timepoint is shown in Figure 5. Exercise Clinic Sessions 1 and 3 show a spread and upper quartile that are within the a priori upper limits of 36 and 109 days respectively. Exercise Clinic Session 2 has a spread that goes outside the a priori upper range of 36 days, with an upper quartile of 39.5 days. Outliers were present at all timepoints and were not excluded from analysis, likely increasing mean values. When observing the median scores only for Exercise Clinic Session 1, 2 and 3 (12.5, 35 and 94 days respectively), feasibility targets were achieved at all timepoints.  4.5 Fidelity of Intervention  4.5.1 Intervention delivery fidelity     The 39 intervention delivery components are summarized in Table 3. The delivery of these components was evaluated for intervention delivery fidelity during Exercise Clinic Session 1, Exercise Clinic Session 3 and a combined score of Exercise Clinic Sessions 1 and 3. Defined as the total number of components delivered at each timepoint, Intervention delivery fidelity was set a priori as >75% of the 39 intervention components, based on the mean score at Exercise Clinic Session 1 and 3. As summarized in Table 5, an average of 37.1±3.7 intervention components (95.1%) were completed at Exercise Clinic Session 1 and an average of 35.1±4.9 intervention components (90.0%) were completed at Exercise Clinic Session 3. Only one participant at Exercise Clinic Session 1 and three participants at Exercise Clinic Session 3 (including the participant identified at session 1) were below the delivery fidelity target of 75%. The total fidelity achieved across all sessions was 92.8% as depicted in Figure 6 and is equivalent to an average of three intervention components being missed overall. Based on the a priori feasibility criteria (>75%), intervention delivery fidelity was achieved at Exercise Clinic 68  Session 1, Exercise Clinic Session 3 and for the combined scores of Exercise Clinic Sessions 1 and 3. 4.5.2 Intervention component fidelity Each of the 39 intervention components were evaluated separately to understand the intervention component fidelity associated with Exercise clinic Sessions 1 and 3. Fidelity was set a priori as >75% and was defined as the number of sessions that included a specific intervention component, evaluated for each of the 39 intervention components. Table 5 and Figure 7 summarize the results. One component, “attended with partner”, did not meet the feasibility criteria and achieved completion scores of 58.7%. All other intervention components met the fidelity criteria. Based on the a priori feasibility criteria (>75%), intervention component fidelity was achieved in 38 of the 39 intervention components for combined timepoint scores.  4.6 Change in self-reported exercise behaviours 4.6.1 Aerobic exercise   Table 6 summarizes the weekly moderate-to-vigorous aerobic exercise levels reported at the education session, Exercise Clinic Session 1 and Exercise Clinic Session 3. At the education session, participants performed an average of 110.9±139 minutes of weekly moderate-to-vigorous aerobic exercise. At Exercise Clinic Sessions 1 and 3, participants performed 165.1±128.8 minutes and 202.6±147.4 minutes of moderate-to-vigorous exercise, respectively. The average change achieved between the education session and Exercise Clinic Session 3 was an increase of 82.9±197.8 minutes of moderate-to-vigorous aerobic exercise with an effect size of 0.54 (95% CI 0.03 – 1.05).  69  A summary of the self-reported weekly aerobic exercise levels at mild, moderate, vigorous and moderate-to-vigorous intensities is depicted in Figure 8. As the exercise clinic progressed (education session to Exercise Clinic Session 3), the volume (mins/week) of aerobic exercise at moderate and vigorous intensities increased and the volume of mild intensity aerobic exercise decreased. At Exercise Clinic Session 1, average moderate-to-vigorous aerobic exercise levels were exceeding the recommended amount of 150 minutes per week and this was increased further at Exercise Clinic Session 3.    4.6.2 Resistance exercise    Table 7 summarizes the weekly resistance exercise levels reported at the education session, Exercise Clinic Session 1 and Exercise Clinic Session 3. At the education session, participants performed an average of 1.4±2.2 sessions of resistance exercise weekly. At Exercise Clinic Session 1 and 3, participants performed 2.0±2.3 sessions and 3.2±2.9 sessions of weekly resistance exercise, respectively. The average change achieved between the education session and Exercise Clinic Session 3 was an increase of 2.0±3.1 sessions of weekly resistance exercise with an effect size of 0.77 (95% CI 0.25 – 1.23).   4.7 Comparison of exercise behaviours: clinic 2.0 and 1.0 4.7.1 Moderate-to-vigorous aerobic exercise   The mean change scores of moderate-to-vigorous aerobic exercise levels from the first session (Exercise Clinic version 2.0 protocol = education session; Exercise Clinic version 1.0 protocol = exercise clinic baseline session) to the 3-month session (Exercise Clinic version 2.0 protocol = Exercise Clinic Session 3; Exercise Clinic version 1.0 protocol = exercise clinic 3-70  month follow-up) are shown in Table 8. Exercise Clinic version 1.0 protocol had low attendance at the 3-month time-point (56.0%, n=79) compared to Exercise Clinic version 2.0 protocol (76.3%, n=29). Overall, moderate-to-vigorous aerobic exercise levels increased by 13.3±147.9 minutes per week for Exercise Clinic version 1.0 protocol and by 82.9±197.8 for Exercise Clinic version 2.0 protocol (Figure 9 and Figure 10). When comparing the change in moderate-to-vigorous aerobic exercise between Exercise Clinic version 2.0 protocol to 1.0 protocol, an effect size of 0.42 (95% CI 0.0 – 0.85) was achieved.   4.7.2 Resistance exercise   The mean change scores of resistance exercise levels from the first session to the 3-month session (as defined above) are shown in Table 8. Exercise Clinic version 1.0 protocol had an average increase of 0.4±1.9 sessions of weekly resistance exercise and Exercise Clinic version 2.0 protocol had an average increase of 2.0±3.2 sessions of weekly resistance (Figure 11 and Figure 12). When comparing the change in resistance exercise sessions between Exercise Clinic version 2.0 protocol to 1.0 protocol, an effect size of 0.63 (95% CI 0.2 – 1.07) was achieved.   4.8 Correlation between self-efficacy and aerobic exercise levels 4.8.1 Self-efficacy and aerobic exercise levels at Exercise Clinic Session 1 As shown in Table 9, a strong correlation (defined as 0.6 – 0.79) was identified between aggregate self-efficacy scores and mean aerobic exercise levels at Exercise Clinic Session 1 for moderate-intensity aerobic exercise (rs=0.71, p<0.001) and moderate-to-vigorous aerobic exercise (rs=0.68, p<0.001). Vigorous-intensity aerobic exercise showed a trend towards 71  correlation, but did not reach significance (rs=0.34, p=0.06). These results indicate that baseline self-efficacy scores and baseline aerobic exercise levels are associated.   4.8.2 Change in self-efficacy and aerobic exercise levels at Exercise Clinic Session 3 A moderate correlation (0.4 – 0.59) was observed when evaluating the change in self-efficacy scores for moderate intensity aerobic exercise and the change in moderate aerobic exercise levels (mins/week), measured between Exercise Clinic Session 1 and 3 (Table 9). Our results failed to show an association existed when evaluating vigorous and moderate-to-vigorous self-efficacy levels against exercise levels.  4.9 Exploratory pre/post measures   The change in 13 different anthropometric and physical function measures captured during Exercise Clinic version 2.0 protocol sessions from Exercise Clinic Session 1 to Exercise Clinic Session 3 is summarized in Table 10. The majority of outcomes measured showed no effect, with three items showing small effects, namely reduction in resting heart rate (ES 0.28, 95% CI -0.23 – 0.79), increase in SPPB sit to stand (ES 0.49, 95% CI -0.04 – 1.03), and improvement in SPPB balance (ES 0.43, 95% CI -0.10 – 0.97). However, the 95% CI of all of these items crossed zero, indicating uncertainty that any effect was achieved. An increase in SPPB total score was the only item that showed a large effect over time (ES 0.65, 95% CI 0.11 to 1.19) and had a 95% CI greater than zero. However, the mean change for SPPB total was 0.3 points on a 12-point scale and this does not meet previously reported clinically meaningful change thresholds, defined as a change of 1.0.136   72  4.10 Tables and Figures Figure 2. Flow of participants through exercise program                       Enrolled to attend education session (n=55) Excluded  (n= 17) • Did not show up (n=17)   Attended Education (n=38) Attended Clinic 1 (n=34)   Education Session Exercise Clinic 2 Exercise Clinic 1 Enrollment Exercise Clinic 3 Excluded  (n= 4) • Discontinued, did not want to attend clinic (n=2) • Delayed start of exercise clinic (n=2)   Attended Clinic 2 (n=29)   Excluded  (n= 5) • Discontinued clinic (n=2) • Missed session (n=3)   Excluded  (n= 3) • Discontinued clinic (n=3) Attended Clinic 3 (n=29)   73  Figure 3. Attendance and attrition at each session of the exercise program                     Note: The dotted line represents target feasibility, 60%. Exercise Clinic attendance was calculated based on the total number of participants who attended the education session compared to the total number who booked in and excluded the 2 participants who delayed the start of the exercise clinic to outside of the study timeline.   Figure 4. Number of sessions of the exercise program that occurred within a priori session timing of the protocol              Note: the dotted line represents the target feasibility, 75%. For session timing, a priori feasibility was as follows: Exercise Clinic Session 1, <36 days after the education session; Exercise Clinic Session 2, 24 – 36 days after Exercise Clinic Session 1; Exercise Clinic Session 3, 73 – 109 days after Exercise Clinic Session 1.  0%10%20%30%40%50%60%70%80%90%100%Education Clinic 1 Clinic 2 Clinic 3MissedAttritionAttendanceBookedParticipant attendance (%) Exercise Clinic Session Type 0%10%20%30%40%50%60%70%80%90%100%Clinic 1 Clinic 2 Clinic 3Sessions within timing protocol (%) Exercise Clinic Session Type 74  Figure 5. Timing of each exercise program session                                  020406080100120140160180200                Note: solid circles represent outliers; x = mean; horizontal line within box = median. For session timing, a priori feasibility was as follows: Exercise Clinic Session 1, <36 days after the education session; Exercise Clinic Session 2, 24 – 36 days after Exercise Clinic Session 1; Exercise Clinic Session 3,  73 – 109 days after Exercise Clinic Session 1.         Exercise              Exercise                Exercise         Clinic 1                Clinic 2                  Clinic 3 Exercise Clinic Session Type 20   180  160  140  120  100  80  60  40  Time to program session (days) 200  180         80  60     0 Exercise     Exercise      Exercise Clinic 1     Clinic 2      Clinic 3 Exercise cli ic session type Time to program session (days) 75  0%10%20%30%40%50%60%70%80%90%100%Combined Clinic 1 Clinic 3Total  components delivered (%) Exercise Clinic Session Type Figure 6. Fidelity of intervention delivery at each program session                     Note: the dotted line represents the a priori feasibility target, 75%. Intervention delivery fidelity is defined as the total number of intervention components that were delivered at each timepoint.   Figure 7. Fidelity of the delivery of each intervention component                     Note: the dotted line represents the target feasibility, 75%. Each intervention component is numbered (1-39) and described in Table 3.    0%10%20%30%40%50%60%70%80%90%100%1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39Intervention component delivered  (% sessions) Intervention component (item number) 76  0 50 100 150 200 250Moderate-to-vigorousVigorousModerateMildBaselineClinic 1Clinic 3Education   Exercise  Clinic 1  Exercise  Clinic 3 Mild-intensity aerobic exercise   Moderate-intensity aerobic exercise    Vigorous-intensity aerobic exercise   Moderate-to-vigorous intensity aerobic exercise  Aerobic exercise (mins/week) Figure 8. Weekly self-reported aerobic exercise levels of each program session                      Note: Exercise Clinic Session 2 was excluded due to the questionnaire administration being different to sessions 1 and 3 (telephone administration vs written questionnaire with validity checking in consultation).     Figure 9. Distribution of aerobic exercise levels of Exercise Clinic version 1.0 and 2.0 protocols at baseline and 3-months   Note: For Exercise Clinic version 1.0 protocol, baseline clinic was the Exercise Clinic Session 1. For Exercise Clinic version 2.0 protocol, baseline clinic was the education session.     Exercise intensity (self-reported) Clinic 1.0 protocol Clinic 2.0 protocol Baseline Clinic 3-month Clinic Exercise Clinic Session Type  Moderate-to-vigorous  exercise (mins/week) 77  Figure 10. Average aerobic exercise levels in Exercise Clinic version 1.0 and 2.0 protocols at baseline, 3-months and change at 3-months                       Note: For Exercise Clinic version 1.0 protocol, baseline clinic was the Exercise Clinic Session 1. For Exercise Clinic version 2.0 protocol, baseline clinic was the education session. Error bars represent standard error (SE). Dotted line represents the target aerobic exercise level (150 minutes) at baseline and 3-month visit.    Figure 11. Distribution of resistance exercise levels of Exercise Clinic version 1.0 and 2.0 protocols at baseline and 3-months                 Note: Median values for baseline clinic 1.0 and 2.0 protocol and 3-month clinic 1.0 protocol are 0. For Exercise Clinic version 1.0 protocol, baseline clinic was the Exercise Clinic Session 1. For Exercise Clinic version 2.0 protocol, baseline clinic was the education session.  Exercise Clinic Session Type  Moderate-to-vigorous  exercise (mins/week) 050100150200250300Baseline Clinic 3-month Clinic Change from baseline to 3-month Clinic 1.0 protocol  Clinic 2.0 protocol Baseline Clinic 3-month Clinic Clinic 1.0 protocol Clinic 2.0 protocol Resistance exercise  (sessions/week) Exercise Clinic Session Type 78  Figure 12. Average resistance exercise levels in Exercise Clinic version 1.0 and 2.0 protocols at baseline, 3-months and change at 3-months                   Note: For Exercise Clinic version 1.0 protocol, baseline clinic was the Exercise Clinic Session 1. For Exercise Clinic version 2.0 protocol, baseline clinic was the education session. Error bars represent standard error (SE). Dotted line represents the target resistance exercise level (2 sessions) at baseline and 3-month visit.   00.511.522.533.544.5Baseline Clinic 3-month Clinic Change from baseline to 3-month Exercise Clinic Session Type Resistance exercise (sessions/week) Clinic 1.0 protocol  Clinic 2.0 protocol 79  Table 4. Participant baseline demographics  Characteristic (n = 34*) Mean (SD) Range (min-max) Age 68.32 (2.58) 55 – 80 Time since diagnosis (days) 24.2 (35.6) 2.2 – 142  Time since joining PCSC program 10.4 (14.9) 0.5 – 53.2  Characteristic (n = 34)  n (%) Age Category        <60 years  2 (5.9)      60 – 64 years  5 (14.7)      65 – 69 years  13 (38.2)      70 – 74 years  9 (26.5)      75+ years  5 (14.7) Marital Status        Married / Common law  28 (82.4)      Single / Divorced  6 (17.6) Highest Education Level        High school or less  3 (8.8)      Non-university diploma or apprenticeship  11 (32.4)      University undergraduate degree  11 (32.4)      Graduate level university  9 (26.5) Employment Status        Employed full-time  9 (26.5)      Employed part-time  2 (5.9)      Retired  22 (64.7)      Unemployed  1 (2.9) Ethnicity        Caucasian  28 (82.4)      South Asian  3 (8.8)      East Asian  2 (5.9)      Other   1 (2.9) Treatments Received        None or Active Surveillance  6 (17.6)      Surgery (e.g. Prostatectomy)  25 (73.5)      Brachytherapy  0      External Beam Radiation Therapy  8 (23.5)      Androgen Deprivation Therapy (ADT)  12 (35.3)      Chemotherapy  0      Other (e.g. clinical trial)  1 (2.9) Treatment Status        None received  6 (17.6)      Previous (> 3-months)  11 (32.4)      Recently completed (<3-months)  9 (26.5)      Current  7 (20.6)      Not reported  1 (2.9) Exercise Levels        Meets both exercise guidelines (aerobic & resistance) 4 (11.8)      Meets no exercise guidelines 16 (47.1)      Meets aerobic exercise guidelines 10 (29.4)      Meets resistance exercise guidelines 9 (26.5)  * Participant demographics are captured at clinic session 1 (n=34). 80  Table 5. Results for feasibility outcomes for exercise program  Feasibility Measure Target % Education Session Clinic 1 Clinic 2  (telephone) Clinic 3 Met Feasibility Target? #1 #2 #3 Attendance (N=36) >60% 38a (69.1% of those booked) 34  (94.4%) 29  (80.6%) 29 (80.6%) Y Y Y Attrition (drop-out) (N=36) <30% N/A 2 (5.6%) 4b  (11.1%) 7 (19.4%) Y Y Y Session timing   (N=34) (N=29) (N=29)    a) Number of sessions within timing protocol  75% N/A 28 (82.4%) 19  (65.5%) 26  (89.7%) Y N Y b) Days from education session (mean, SD) N/A N/A 19.0±18  N/A N/A    c) Days from baseline session (mean, SD) N/A N/A N/A 36.4±7 98.2±21    Fidelity of intervention:         Intervention delivery fidelity  mean±SD (%) (N = 39)c 75% N/A 37.1 ±3.7 (95.1%) N/A 35.1±4.9  (90.0%) Y N/A Y  Intervention component fidelity (N=63)d  75%                              92.8%                             Component 3: 58.7%         N/A              All other components:                             >75% completion   Y (except      component 3e)    Data shown is N (%) unless otherwise stated. Y = yes; N = no; N/A = Not applicable; SD = standard deviation. For session timing, target timing for Exercise Clinic Session 1 was <36 days after the education session; Exercise Clinic Session 2 was 24 – 36 days after Exercise Clinic Session 1; Exercise Clinic Session 3 was 73 – 109 days after Exercise Clinic Session 1.  a 2 participants delayed starting the exercise clinic after attending the education session and have been excluded from all additional analysis beyond education session attendance. b 3 participants missed Exercise Clinic Session 2, and did attend Exercise Clinic Session 3. They are not counted in the attrition data at Exercise Clinic Session 2 because they continued in the program. c N=39 represents the total intervention components that were measured for each participant.  d N=63 represents all sessions that were conducted at Exercise Clinic Sessions 1 and 3. Intervention component fidelity was calculated using all 63 sessions that occurred at either Exercise Clinic Session 1 or 3. e Component 3 was the question “Attended with spouse? Y/N”     81  Table 6. Change in weekly self-reported moderate-to-vigorous aerobic exercise levels across the exercise program  Value (mins/week) Education (n=32) Clinic 1 (n=34) Clinic 3 (n=29) Change at Clinic 3 (n=29) ES Mean  110.9 165.1 202.6 82.9 0.54 SD  139.0 128.8 147.4 197.8  95% CI 60.8 to 161.1 120.1 to 210.0 146.5 to 258.6 7.7 – 158.1 0.03 – 1.05 Median 67.5 160 180 35  Range 0 to 480 0 to 480 0 to 490 -420 to 480   Note: change score reflects the change in minutes per week from the education session to Clinic 3. At the education session, data was missing for n=2.   Table 7. Weekly resistance exercise volume of exercise clinic 2.0 protocol  Value (sessions/week) Education (n=32) Clinic 1 (n=34) Clinic 3 (n=29) Change at Clinic 3 (n=29) ES Mean 1.4 2.0 3.2 2.0 0.77 SD 2.2 2.3 2.9 3.1  95% CI 0.6 to 2.2 1.2 to 2.8 2.1 to 4.3 0.8 to 3.2 0.3 to 1.3 Median 0 1.5 3 1  Range 0 to 6 0 to 6 0 to 14 -2 to 14   Note: change score reflects the change in sessions per week from the education session to Clinic 3. At the education session, data was missing for n=2.               82  Table 8. Comparison of Exercise Clinic version 1.0 and 2.0 protocols: Exercise Levels  Exercise Measure Drop-outs  (not analyzed) Mean Δ at  3-months SD 95% CI mean Δ  ES 95% CI for ES Moderate to vigorous aerobic exercise Clinic 1.0 protocol (N=141, 79 analyzed) N=62 13.3 mins/week 147.9 -19.3 to 45.9 0.07 -0.21 to 0.35 Clinic 2.0 protocol (N=34, 29 analyzed)  N=5 82.9  mins/week 197.8 10.9 to 155 0.54 0.03 to 1.05 Exercise Clinic 2.0 protocol VS Exercise clinic 1.0 protocol:  0.42* 0.00 to 0.85 Resistance exercise Clinic 1.0 protocol Resistance Exercise (N=141, 79 analyzed) N=62 0.4 Sessions/week 1.9 -0.02 to 0.82 0.29 0.01 to 0.56 Clinic 2.0 protocol Resistance Exercise (N=34, 29 analyzed) N=5 2.0 3.2 0.84 to 3.16 0.77 0.30 to 1.30 Exercise Clinic 2.0 protocol VS Exercise Clinic 1.0 protocol  0.63* 0.20 to 1.07  * A positive effect size (ES) favours Exercise Clinic 2.0 protocol. All effect sizes include a Hedges g correction for unequal sample sizes.156 An ES of 0.2 = small, 0.5 = medium, 0.8 = large.156 Δ = change from education session.     83  Table 9. Correlation between self-efficacy score and aerobic exercise levels  Correlation rs p-value Clinic 1 self-efficacy score (aggregate) & Clinic 1 aerobic exercise level (mins/week) Self-efficacy (moderate exercise) & moderate-intensity aerobic exercise  0.71 <0.001* Self-efficacy (vigorous exercise) & vigorous-intensity aerobic exercise  0.34 0.06 Self-efficacy (moderate and vigorous exercise) & moderate-to-vigorous intensity aerobic exercise 0.68 <0.001* Change in self-efficacy score (aggregate) & change in aerobic exercise level (mins/week) Change in self-efficacy (moderate exercise) & change in moderate aerobic exercise 0.43 0.03* Change in self-efficacy (vigorous exercise) & change in vigorous aerobic exercise  0.04 0.83 Change in self-efficacy (moderate and vigorous) & change in moderate-to-vigorous aerobic exercise  0.15 0.47  Note: Change in self-efficacy and exercise levels was measured between Exercise Clinic Session 1 and Exercise Clinic Session 3.    * Correlation is significant at the 0.05 level (2-tailed)   84  Table 10. Pre-post changes during Exercise Clinic version 2.0 protocol   Exercise Clinic  session 1 Exercise Clinic  session 3 Mean change from clinic 1 to clinic 3 (SD) ES (95% CI) Mean (SD) Median Mean (SD) Median Systolic Blood Pressure (mmHg) 128.3 (11.2) 128 130.4 (14.6) 131 2.1 (13) 0.16  (-.35 to .67) Diastolic Blood Pressure (mmHg) 77.2 (7.4) 80 78.4 (7.3) 80 1.1 (8.9) 0.16  (-.35 to .67) Resting Heart Rate (bpm) 66.6 (8.7) 68 69.4 (11.2) 67 1.7 (9.6) 0.28  (-.23 to .79) BMI (kg/m2) 26.4 (3.0) 26.5 26.5 (3.2) 26.4 0.2 (0.7) 0.03  (-.48 to .54) Waist Circumference (inches) 39.4 (3.3) 40.1 39.2 (3.2) 39.8 0.1 (1.5) -0.06  (-0.57 to .45) FACIT-Fatigue 38.5 (9.7) 40.5 37.8 (9.9) 41 0.3 (8.6) -0.07  (-0.57 to 0.43) VAS-Fatigue 3.3 (2.1) 3 3.1 (2.3) 2 - 0.4 (2.4) -0.09  (-.59 to .41) SPPB (total) 11.7 (0.6) 12 12 (0) 12 0.3 (0.5) 0.65  (0.11 to 1.19) SPPB (5-rep STS) 3.8 (0.5) 4 4.0 (0.2) 4 0.1 (0.4) 0.49  (-0.04 to 1.03) SPPB (Balance) 3.9 (0.3) 4 4.0 (0) 4 0.1 (0.3) 0.43  (-0.10 to 0.97) SPPB (Gait speed) 4.0 (0.2) 4 4.0 (0) 4 0.04 (0.2) 0.00  (-0.53 to 0.53) Handgrip strength (combined score, Kg) 72.7 (17.0) 70.6 75.9 (15.9) 75.4 2.6 (6.0) 0.19  (-0.34 to 0.72) Exercise enjoyment (1-5) 3.7 (1.2) 4 3.8 (1.4) 4 - 0.1 (1.1) 0.08  (-0.43 to 0.58)  Note: No clinically meaningful changes were found. All effect size 95% confidence intervals shown cross 0 except for SPPB (total).        85  Chapter 5: Discussion This study evaluated the delivery of exercise counselling by exercise physiologists to individuals with prostate cancer as part of a real-world clinical program. The primary aim was to analyze the feasibility of delivering the PCSC Exercise Clinic version 2.0 protocol to prostate cancer survivors from a clinical setting. Overall, the study met the a priori feasibility targets at all timepoints (Education session, Exercise Clinic Sessions 1, 2 and 3) for attendance, attrition and intervention delivery fidelity. Session timing fidelity met a priori targets at Exercise Clinic Session 1 and Session 3 and was close to a priori targets at Session 2 (delivered by telephone) and for intervention component fidelity (38 of the 39 items met fidelity). Overall, the intervention protocol was shown to be feasible to deliver to individuals with prostate cancer in a clinical setting and had high attendance, low attrition and strong intervention fidelity. Additionally, the PCSC Exercise Clinic version 2.0 protocol had moderate-to-large clinically meaningful effects on exercise behaviours, increasing weekly aerobic and resistance exercise levels with the majority of participants meeting the minimum exercise recommendations for cancer survivors. This indicates that the Exercise Clinic version 2.0 protocol is feasible to deliver from a real-world clinical setting by exercise physiologists, effective at increasing aerobic and resistance exercise behaviours over 3-months, and appeared superior to the Exercise Clinic version 1.0 protocol.  5.1 Exercise Clinic version 2.0 key components The Exercise Clinic version 2.0 protocol was developed based on key elements noted to be associated with superior behaviour change, and from what was learned in the preliminary evaluation of the Exercise Clinic version 1.0 protocol.13,30,93-98,101,105 Key innovations that were 86  incorporated into the Exercise Clinic version 2.0 protocol included: 1) Mandating group-based education prior to attending the one-on-one exercise counselling; 2) Delivering the intervention through a set clinical protocol that included appointment time-frames; 3) Individualized instruction on how to perform the aerobic and resistance exercise behaviour, printed exercise programs and self-monitoring tracking sheets; 4) Review of exercise behaviours and goals via telephone consultation at 1-month; and 5) Measurement of task self-efficacy, exercise enjoyment, detailed exercise barriers and physical performance (i.e. SPPB and grip strength). It is possible that by mandating the group-based education sessions as the entry point to the exercise clinic that participants may have improved their understanding of the importance of exercise for prostate cancer and were able to discuss more specific topics during their exercise counselling sessions. This may have influenced the improvements seen in the Exercise Clinic version 2.0 protocol. Further research would need to be conducted to confirm this. In addition to the components listed above that were included in the 2.0 protocol only, the Exercise Clinic version 1.0 and 2.0 protocols both included the following items: 1) Exercise counselling delivered by an exercise physiologist in a medical setting; 2) Co-constructed goal setting (between exercise physiologist and patient) and detailed action planning; 3) Fatigue measurement, barrier identification and problem solving; 4) Review of goals, feedback on performance and re-evaluation at follow-up appointments; 5) Setting graded exercise tasks; instruction and demonstration of target behaviour; and 6) Patient-centred approach to exercise counselling. While the inclusion of specific BCTs within the program was documented, a more detailed evaluation would be required to understand the interaction each BCT has on exercise behaviours over short and long-term timeframes. This would need to be performed under 87  controlled research conditions (i.e. RCT or factorial design) to identify the active ingredients, prior to being tested for effectiveness in a real-world setting.    5.2 Change in aerobic and resistance exercise behaviours The secondary aim of this study was to evaluate the preliminary effect of the intervention at changing aerobic and resistance exercise levels over 3-months. Our results show a mean increase of 83±198 minutes of moderate-to-vigorous aerobic exercise and 2.0±3.1 sessions of resistance exercise per week, which demonstrated a moderate effect for aerobic exercise (ES 0.54, 95% CI 0.3-0.5) and large effect for resistance exercise (ES 0.77, 95% CI 0.3-1.3). The increases in self-reported moderate to vigorous aerobic exercise observed with the PCSC Exercise Clinic version 2.0 protocol are similar to those observed in efficacy studies that include supervised exercise performed in a research setting, as summarized in a recent meta-analysis by Grimmett et al (2019) as a mean increase of 65 minutes per week (95% CI 45.6 – 85.0) with a similar effect size (SMD 0.49, 95% CI 0.32 – 0.66).101 We found greater improvements than a similar real-world non-randomized single arm feasibility study involving a pharmacist-delivered exercise counselling intervention in prostate cancer survivors by Lemanska et al (2019) that achieved increases in MVPA of 34 minutes per week.116 One major difference between our study and Lemanska et al (2019) is that our intervention was delivered by exercise physiologists, which patients have previously reported to be their preferred provider of exercise counselling.38,39,42 To test if the professional delivering the intervention impacts the behaviour change achieved, further researched would need to be performed under more controlled conditions.   88  The potential change in resistance exercise levels in efficacy studies have been seldom reported in the literature, making comparisons between our study and previous studies difficult. However, in contrast to the results of a RCT by Forbes et al (2015) that reported an increase of 0.5 (95% CI -0.2-1.0) resistance exercise sessions per week after a 10-week internet-supported intervention and effect of 0.34, the results of our study show an increase of 2.0 (95% CI 0.87-3.13) resistance exercise sessions per week, and an effect of 0.77. This suggests that our approach was successful at empowering men to reach the current resistance training guidelines.110 Overall, our intervention appears to elicit similar effects on aerobic and resistance exercise levels compared to supervised aerobic exercise interventions and distance-based resistance exercise interventions that were delivered under more controlled research conditions. However, further research under more controlled conditions would need to be performed to confirm both the efficacy and the effectiveness of this intervention.  The tertiary aim of this study was to evaluate the association between task self-efficacy and aerobic exercise levels. Based on previous research on social cognitive theory of behaviour change, we hypothesized that higher task self-efficacy at exercise clinic session 1 would be correlated with higher exercise levels, and that greater change in task self-efficacy at Exercise Clinic Session 3 would be associated with larger changes in aerobic exercise levels at 3-months. We found that self-efficacy levels for moderate-intensity and moderate-to-vigorous intensity aerobic exercise at Exercise Clinic Session 1 were moderately correlated with aerobic exercise levels of the same intensity. However, we did not find any strong associations between the change in self-efficacy levels at 3-months and the change in aerobic exercise levels. This lack of effect may be due to the small sample size of our study, the timeframe of 3-months being too short a follow-up period to see a change in self-efficacy levels or a mechanism other than self-89  efficacy responsible for driving the behaviour change. Given that previous research highlights the importance of self-efficacy for behaviour change, we encourage further evaluation of this area once more participant data is available.119-121,145 Additionally, due to the inclusion of resistance exercise and strong improvements seen in our study, we believe that a task self-efficacy question that addresses resistance exercise would also be beneficial to include in the Exercise Clinic version 2.0 protocol.  5.3 Behaviour change techniques Previous research highlights that the delivery method of a BCT to an individual may be more important than the specific BCT itself.34,95-101 Our intervention included many different BCTs, delivered across both the education session and exercise clinic sessions, with a focus on educating the individual, teaching and demonstrating the required skills, adapting the exercise prescription or advise to the individual, and providing ongoing support. This approach to increasing physical activity levels is supported by multiple studies that suggest teaching a skill or active discussion combined with an intervention that is adapted specifically to an individual achieves greater behaviour change.97,98 Additionally, previous research into interventions that have the greatest effects on physical activity levels shows that a combination of both home-based and facility-based settings can achieve the greatest behaviour change.97,98 Our intervention combined both home and facility-based settings and found similar effects in moderate-to-vigorous aerobic exercise (ES 0.54, 95% CI 0.3-0.5) as the meta-analysis by Finne et al (2018) (ES 0.39, 95% CI 0.28-0.49) which evaluated the effectiveness of BCTs at increasing physical activity in cancer survivors.97 The combination of home and facility-based settings may be successful due to the medical-setting being reported as a “safe learning environment” by 90  participants in the study by Schmidt et al (2019) that explored the perspectives of prostate cancer survivors on transitioning exercise from medical to home-based and community settings.105 Given that prostate cancers have a high willingness to engage in aerobic and resistance exercise, this setting may provide them with the necessary components to create initial behaviour change.28,37,38,105 Schmidt et al (2019) identified other key components to include in a structured transition plan, namely support, monitoring, and individualized programming, all of which are easily delivered through exercise counselling interventions, including ours.105 One additional component that was not measured in our study that may be important for future studies to measure is the evaluation of the interaction or rapport that is built between the exercise physiologist and the participant. We believe that all of these factors are likely important to support prostate cancer survivors to change exercise behaviours. Future studies should consider the inclusion of measures (e.g. evaluating rapport) or comparative evaluations (e.g. between the delivery setting, the professional delivering the intervention or the specific site) that allow for a deeper understanding of the interaction of these components. Finally, whilst research shows uncertainty about the most effective number of BCTs to include in an intervention or the combination of BCTs that are most efficacious for exercise behaviour change, some similarities exist amongst more promising interventions, including ours.34,95-101 This includes the BCTs of goal setting, interventions designed around individual capabilities, social support and rewards (e.g. praise), prompts or cues, and setting graded tasks.34,95-101 All of these suggested BCTs were included within the Exercise Clinic version 1.0 and 2.0 protocols, but were further supported in the 2.0 protocol with additional prompts and cues (i.e. appointment reminders, a 1-month follow-up telephone consultation, printed exercise programs and exercise recording logs) and a very structured delivery protocol (Figure 1). 91  Considering that this was the main difference between protocols 1.0 and 2.0 and that large improvements were found in exercise volumes from the 2.0 Clinic, it is possible that the addition of these extra items contributed to the increased exercise behaviours achieved by the Exercise Clinic version 2.0 protocol. These additional BCTs enabled active discussion and demonstration of behaviour, which was identified in the systematic review by Hallward et al (2018) to be important. Including mandated education as the starting point for the intervention may have positively influenced the behaviour change achieved by the exercise counselling clinic, allowing it to be more tailored to the individual’s needs. The 1-month follow-up telephone consultation was used to problem solve any barriers and to prompt activation of the graded exercise tasks. Additionally, the printed exercise programs were demonstrated and taught to the individuals and also individually tailored and pragmatically designed to be easy to perform from a home-based setting. Whilst the individual mechanisms driving the behaviour change in our study cannot be identified from the current study design, it appears to support previous research by Turner et al (2018) and Hallward et al (2018) that suggests actively involving the participant by teaching, demonstrating and actively discussing the BCTs are important drivers of change.   5.4 Implementation into a “real world” clinical setting Few studies have reported on the “real world” implementation of supportive care interventions in prostate cancer survivors.10,51,105,113 Barriers to program implementation have been reported to include lack of referral pathways, funding, space and qualified staff and reports have urged researchers to rethink implementation strategy, engage key stakeholders and explore different study designs.31,102-104 Our intervention used exercise counselling delivered by exercise physiologists in an attempt to overcome the majority of implementation barriers as it does not 92  require large amounts of space, can be implemented from within a medical setting, and enables an individualized approach to exercise prescription. This aligns with the findings from Stone et al (2019) in an evaluation of determinants of physical activity behaviour change in prostate cancer survivors.93 They found that to best elicit exercise behaviour change, interventions should include strategies that mitigate barriers, address detrimental determinants and implement programs that support inactive individuals to adopt exercise and active individuals to maintain exercise. Exercise Clinic version 2.0 protocol delivered all of these recommendations.93  Additionally, using a highly qualified exercise professional (e.g. exercise physiologist) to deliver this intervention enabled all patients to be invited to participate, including higher-risk individuals such as those currently receiving treatments and men who had advanced cancer (i.e. bone metastases). The use of highly qualified exercise professionals has been previously shown to be an exercise facilitator for prostate cancer patients and in our study enabled an ‘all-comers’ approach to be taken.30,32,37,38,42,98 Our baseline data shows that the majority of participants of the Exercise Clinic version 2.0 protocol did not meet both exercise guidelines (88.2%) and had baseline levels of moderate-to-vigorous aerobic exercise of 110 mins/week. We believe that this highlights that a self-referred ‘all-comers’ approach to recruitment in our setting appears to have attracted the participants we were most interested in, namely those who were insufficiently active. This is different to findings from Lemanska et al (2019) that evaluated a pharmacist delivered exercise counselling intervention and reported baseline levels of MVPA averaging 245 mins/week, indicating that they recruited individuals who were already very active.113 A major strength of our intervention was the strong feasibility outcomes for attendance and fidelity and the low attrition that occurred over 3-months. We believe that this was in-part due to the detailed information on intervention delivery timeframes that was included in our 93  protocol and followed by the exercise professionals and administrative personnel involved in the intervention (Figure 1 and Table 1). Similar to a previous study by Bultijnck et al (2018) that used a clinical pathway to improve the delivery of a supportive care intervention to men on ADT, we achieved a feasible implementation of Exercise Clinic version 2.0 protocol within a clinical setting by providing detailed guidance on intervention delivery.10 Our results demonstrate greater attendance, lower attrition, strong intervention fidelity and larger improvements of aerobic and resistance exercise behaviours than our previous Exercise Clinic version 1.0 that did not include detailed delivery information. A previous study by Lopez et al (2019) that evaluated a physiotherapy-led exercise counselling intervention from within a clinical setting and did not use a specific delivery protocol reported that only 31% of participants attended two or more sessions.51 In contrast, over a similar timeframe, our study had 81% of participants attend two or more times at intervals defined by our protocol.51  In summary, the Exercise Clinic version 2.0 protocol is a feasible model of exercise counselling to be delivered by an exercise physiologist from a clinical setting. Our results indicate that this intervention can achieve a moderate effect and increase both aerobic and resistance exercise levels across a 3-month timeframe in individuals with prostate cancer. Further evaluation is required to understand the long-term effect of this intervention and to identify the active ingredients that contribute to exercise behaviour change.   5.5 Strengths, limitations and considerations To our knowledge, this is the first evaluation of an exercise counselling clinic delivered by exercise physiologists within a real-world clinical care setting for prostate cancer survivors. One strength of this study was the delivery method of the exercise counselling program, 94  designed to overcome many of the common identified barriers to program implementation and behaviour change. Additionally, a heterogeneous sample was recruited, reflective of demographics and range of medical management of men with prostate cancer in BC, most of whom were not sufficiently active, showing that this intervention can be adapted for delivery to all prostate cancer survivors. Additional strengths also included the detailed delivery protocol to guide implementation, a program embedded in a real-world clinical setting, delivery of the intervention by an experienced exercise physiologist, and the input of multiple stakeholders in the program design. One major limitation of this study was the study design. The single-arm retrospective chart review is a pragmatic study design for a real-world setting, however, disadvantages include: 1) an inability to determine causality from the findings; 2) confounding variables may have been present that were not measured; and 3) retrospective chart reviews are considered to be an inferior level of evidence, compared with prospective studies.161-163 Additional risk of bias can include non-blinded data abstractors, investigator conflict of interest bias and data misclassification, all of which are hard to control for with this type of study design.161-163 We attempted to minimize bias in our design through well-defined research questions, defining study variables a priori, using standardized data extraction, and including research ethics board (REB) approval.  Another limitation of this study when considering the secondary and tertiary aims is the small sample size. A larger sample size would have allowed tests of significance to be performed to better understand the intervention effect within specific groups of prostate cancer survivors (e.g. stage, treatment type, age). We attempted to minimize the issue of a small sample size by choosing evaluation methodology that focused on measures not heavily influenced by sample 95  size (i.e. effect size calculations rather than test of significance). An additional limitation of this study is the use of self-reported measures of physical activity. While most practical for the study design, self-report physical activity has previously been shown to have issues with recall bias, social desirability bias and incorrect classification of exercise intensity. We attempted to minimize the issue of these issues by choosing a questionnaire that was short, asked for recent information and provided examples of typical exercise at each intensity. Further, each questionnaire was reviewed with the exercise physiologist to assist in validating and correcting (with the participant) the exercise intensity that was performed. Finally, one potential evaluation limitation is that with the exception of exercise levels which are first evaluated at the education session, all baseline measures are obtained at the Exercise Clinic Session 1. It is recommended that the PCSC program considers the administration of baseline paperwork at the education session, given it is the start of this protocol. Additionally, it is recommended that a prospective evaluation of this “real world” intervention be considered to enhance the methodological rigour of future evaluations. Overall, optimizing the delivery of exercise interventions in real-world clinical settings requires detailed understanding of the problem the intervention is trying to solve, the implementation setting, the overall effect of the intervention and the feasibility of the delivery of the intervention. Extensive previous research highlights the problem our intervention was trying to solve, namely, that prostate cancer survivors are insufficiently active.28,76,78 Our research adds to the literature by providing feasibility data for the implementation of an exercise counselling intervention and also by showing the effect of this intervention at increasing aerobic and resistance exercise levels of men with prostate cancer from within a “real-world” setting. More research is required to understand long-term adherence to exercise of participants who have 96  completed 6- and 12-months of the Exercise Clinic version 2.0 protocol. The delivery of the Exercise Clinic version 2.0 protocol is currently ongoing in three locations within the PCSC Program across British Columbia and further evaluations will be possible. Additionally, more research is required to understand the specific active ingredients that are contributing to the behaviour change that was shown in this study. Finally, future research is needed that looks specifically at the efficacy of this intervention compared to other types of  exercise interventions (e.g. exercise counselling vs supervised exercise) under more controlled research settings.   97  Chapter 6: Conclusion   Individuals with prostate cancer can benefit greatly from achieving the recommended levels of aerobic and resistance exercise, across all stages of the prostate cancer disease trajectory.11-17 Exercise has been consistently shown to be efficacious at preventing, managing and overcoming the common side effects of prostate cancer treatments, such as fatigue, body composition changes, declines in physical function and overall long-term health.13-17 Most individuals with prostate cancer are insufficiently active and to address this efficacious strategies that can be implemented into clinical settings are needed.28,76,78 Exercise counselling is one strategy that has potential to incorporate key behaviour change techniques and be delivered from clinical settings using minimal resources.44-51 However, a lack of evidence exists that demonstrates the effectiveness of exercise counselling to increase exercise behaviours in prostate cancer survivors or evaluates the feasibility of delivery of an exercise counselling intervention from within a real-world clinical setting.  In British Columbia, the PCSC Program includes an exercise module that provides an exercise counselling clinic and exercise education that is delivered using a defined protocol (Exercise Clinic version 2.0 protocol).55,56 The primary aim of our study was to test the feasibility of delivery of the Exercise Clinic version 2.0 protocol in a real-world clinical setting. Feasibility was defined through attendance, attrition, session timing, intervention delivery fidelity and intervention component fidelity, and a priori feasibility targets were used. We hypothesized that the Exercise Clinic version 2.0 protocol would be feasible to deliver from the PCSC program. Our results show that the Exercise Clinic version 2.0 protocol is feasible to deliver by exercise physiologists in a real-world clinical setting. 98  Our secondary aim was to evaluate the preliminary effect of the Exercise Clinic version 2.0 protocol at improving exercise behaviours of prostate cancer survivors at 3-months, and to compare this to the results of the Exercise Clinic version 1.0 protocol. We hypothesized that the 2.0 protocol would improve exercise behaviours of prostate cancer survivors at 3-months and that this would be greater than the results of the 1.0 protocol. Our results show that the Exercise Clinic version 2.0 protocol achieved moderate-to-large effects, improving both aerobic and resistance exercise behaviours over 3-months. When compared to the Exercise Clinic version 1.0 protocol, we found the 2.0 protocol had larger effect sizes, especially for resistance exercise. We believe that there are multiple components of the Exercise Clinic version 2.0 protocol that enabled it to achieve the changes found. Primarily, the BCTs and delivery of BCTs by the exercise physiologist are important elements that have been previously shown to assist in improving exercise behaviours.30,37,41,98 Starting the exercise clinic with a group-based education session, prior to one-on-one exercise counselling, also appears to have been a key component in our intervention. In addition to this, the combination of the facility-based and home-based setting that participants used to learn and perform their exercise behaviours is possibly important.97,98 Finally, the implementation and delivery of the exercise counselling intervention was guided by a detailed delivery protocol that appeared to assist in the successful implementation of this protocol within the real-world clinical setting. Ultimately, more research would need to be performed under controlled conditions to test these elements and to understand if they were active drivers of the exercise behaviour change and clinic implementation. The major findings from this study support the inclusion of an exercise counselling intervention within real-world clinical settings for individuals with prostate cancer as a feasible intervention that can achieve a moderate effect on aerobic and resistance exercise levels. Our 99  results suggest that improvements similar to supervised interventions may be possible in aerobic and resistance exercise levels over 3-months by an exercise counselling protocol delivered by exercise physiologists. Our results show strong feasibility of the delivery of this protocol from within a real-world clinical setting and an ability to deliver this to a heterogenous sample of prostate cancer survivors.  The major strengths of our study were the ability of the intervention to overcome common implementation barriers (e.g. space and equipment requirements, and the complex needs of individuals with prostate cancer), the heterogeneous sample included in the intervention, and the detailed delivery protocol that guided the intervention. The limitations of this study included the retrospective study design, which we attempted to strengthen through a priori protocol detail; the small sample size, which we attempted to overcome through our evaluation methodology; and the use of self-reported measures of aerobic and resistance exercise levels, which we strengthened through validity checking with the exercise physiologist during clinic sessions. Future research into the combination of BCTs that actively drive the behaviour change of prostate cancer survivors should be considered. This could be done using a multi-phase optimization strategy (i.e. MOST approach) that integrates a factorial study design to understand the BCTs that positively and negatively contribute to exercise behaviour change. 164,165 It is recommended that additional research be considered by the PCSC Program that evaluates the exercise behaviour change after 6- and 12-months of the exercise counselling intervention, to understand the long-term adherence and maintenance of the behaviour change found in our study. Finally, it is recommended that controlled trials powered to evaluate the efficacy of an exercise counselling intervention in prostate cancer survivors are performed. 100  The main findings from this study support exercise counselling as a feasible intervention option that can elicit a moderate increase the aerobic and resistance exercise levels of prostate cancer survivors from within a real-world clinical setting. 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Delivered by a clinical counsellor.    118  Appendix B    Modified Godin Leisure Time Exercise Questionnaire (GLTEQ)    119  Appendix C  PCSC Program Aerobic exercise home program     120       121  Appendix D  PCSC Program Aerobic exercise home program log sheet     122  Appendix E  PCSC Program Personal History Questionnaire (PHQ)   123  Appendix F  Get Active Questionnaire (GAQ)  124    125   126   127  Appendix G  Exercise barriers and task self-efficacy questionnaire    128      129  Appendix H  Fatigue questionnaires: FACIT-Fatigue and Fatigue Visual Analogue Scale   130  Appendix I  Exercise Clinic version 2.0 protocol: Data collection sheet   131     132     133  Appendix J  PCSC Resistance training program example  134    135    136    137  Appendix K  PCSC Program Exercise clinic participant results overview   138  Appendix L  PCSC Program Exercise Clinic version 2.0 protocol 1-month data collection sheet   139  Appendix M  Behaviour change techniques included in Exercise Clinic version 2.0 protocol # BCT Included in 2.0? Description of inclusion 1 Provide info on consequences of behaviour in general Yes  Education session & exercise clinic 2 Provide info on consequences of behaviour to the individual Yes Exercise clinic 3 Provide info about others’ approval No  4 Provide normative info about others’ behaviour Yes Education session & exercise clinic 5 Goal setting (behaviour) Yes Education session & exercise clinic 6 Goal setting (outcome) Yes Exercise clinic 7 Action planning Yes Exercise clinic 8 Barrier identification / problem solving Yes Education session & exercise clinic 9 Set graded tasks Yes Education session & exercise clinic 10 Prompt review of behavioural goals Yes Exercise clinic 11 Prompt review of outcome goals Yes Exercise clinic 12 Prompt rewards contingent on effort or progress towards behaviour Yes Exercise clinic 13 Provide rewards contingent on successful behaviour No  14 Shaping No  15 Promoting generalization of a target behaviour Yes Exercise clinic 16 Prompt self-monitoring of behaviour Yes Education session & exercise clinic 17 Prompt self-monitoring of behavioural outcome Yes Exercise clinic 18 Prompt focus on past success Yes Exercise clinic 19 Provide feedback on performance Yes Exercise clinic 20 Provide information on where and when to perform the behaviour Yes Exercise clinic 21 Provide instruction on how to perform the behaviour Yes Exercise clinic 22 Model/demonstrate the behaviour Yes Education session & exercise clinic 23 Teach to use prompts/cues Yes Education session & exercise clinic 24 Environmental restructuring Yes Exercise clinic 25 Agree behavioural contract No  26 Prompt practice Yes Education session & exercise clinic 27 Use of follow-up prompts Yes Exercise clinic 28 Facilitate social comparison No  29 Plan social support/social change Yes Exercise clinic 30 Prompt identification as role model/position advocate No  31 Prompt anticipated regret No  32 Fear arousal Yes Education session 33 Prompt self-talk No  34 Prompt use of imagery No  35 Relapse prevention/coping planning Yes Exercise clinic 36 Stress management/emotional control training No  37 Motivational interviewing Yes Exercise clinic 38 Time management Yes Education session & exercise clinic 39 General communication skills training No  40 Stimulate anticipation of future rewards No  * Based on Michie et al (2013) and Michie et al (2011).95,96 

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