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Efficacy of night-time compression for breast cancer related lymphedema (LYNC): protocol for a multi-centre,… McNeely, Margaret L; Campbell, Kristin L; Webster, Marc; Kuusk, Urve; Tracey, Karen; Mackey, John Aug 4, 2016

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STUDY PROTOCOL Open AccessEfficacy of night-time compression forbreast cancer related lymphedema (LYNC):protocol for a multi-centre, randomizedcontrolled efficacy trialMargaret L. McNeely1*, Kristin L. Campbell2, Marc Webster3, Urve Kuusk4, Karen Tracey5 and John Mackey6AbstractBackground: Lymphedema is a prevalent long-term effect of breast cancer treatment that is associated withreduced quality of life. More recent observational data suggest that the addition of night-time compression today-time use of a compression garment results in better long-term control of arm lymphedema. The primaryobjectives of the randomized controlled phase of the trial are to determine the efficacy of night-time compression onarm lymphedema volume maintenance and quality of life in breast cancer survivors who have completed intensivereduction treatment for their lymphedema.Methods/Design: The study will be a parallel 3-arm, multi-centre randomized fast-track trial. A total of 120 womenwith breast cancer related lymphedema will be recruited from 3 centres in Canada and randomized to group 1:Day-time compression garment alone or Group 2: Day-time compression garment + night-time compressionbandaging or Group 3: Day-time compression garment + use of a night-time compression system garment. Theduration of the primary intervention period will be 12 weeks. The follow-up period after the intervention (weeks13 to 24) will follow a longitudinal observational design. The primary outcome variables: differences from baselineto week 12 in arm volume and quality of life (Lymphoedema Functioning, Disability and Health Questionnaire:Lymph-ICF). Secondary outcomes include bioimpedance analysis, sleep disturbance and self-efficacy. Allmeasurements are standardized and will be performed prior to randomization, and at weeks 6, 12, 18 and 24.Discussion: The use of night-time compression as a self-management strategy for chronic breast cancerrelated lymphedema is seen as an innovative approach to improve long-term control over the condition. Thistrial aims to advance the knowledge on self-management strategies for lymphedema.Trial registration: This trial was registered at clinicaltrials.gov on July 9th, 2014 (NCT02187289)Keywords: Breast cancer, Lymphedema, Compression therapy, Physical therapyAbbreviations: CB, Compression bandaging; DLT, Decongestive lymphatic therapy; MLD, Manual lymphaticdrainage; NCSG, Night-time compression system garment* Correspondence: mmcneely@ualberta.ca1Department of Physical Therapy, University of Alberta & Cross CancerInstitute, 2-50 Corbett Hall, Edmonton, Alberta T6G 2G4, CanadaFull list of author information is available at the end of the article© 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.McNeely et al. BMC Cancer  (2016) 16:601 DOI 10.1186/s12885-016-2648-8BackgroundBreast cancer is the most common cause of cancer inCanadian women with an estimated 25,000 developingthe disease in 2015 [1]. With a current 5-year survivalrate of 88 %, a substantial number of women in Canadaare living with a history of breast cancer [1]. One of themore frequent complications following treatment forbreast cancer is lymphedema, a significant swelling ofthe arm that occurs on the surgical side. Lymphedema isa lifelong condition that tends to worsen over time [2].Recent data suggest that approximately 21 % of womenwho undergo treatment for their breast cancer are diag-nosed with lymphedema [3]. Of these cases, approximatelyhalf will develop chronic progressive lymphedema [4, 5].The impact of lymphedema on the breast cancer sur-vivor is often profound, resulting in negative changes inself-image, increased anxiety, and poorer quality of life[6, 7]. Overtime, lymphedema can create considerabledisability with recurrent infections in the limb, func-tional impairment, and pain [2, 8]. Many survivors seelymphedema as an ongoing reminder of cancer to them-selves, friends, and family [6]. Compounding the prob-lem is that survivors report receiving limited supportand inadequate or conflicting information on the condi-tion and its treatment from healthcare providers [6]. In amatched cohort analysis of breast cancer survivors withand without lymphedema, those with lymphedema hadsignificantly higher medical costs at 2 years (range of$14,877 to $23,167) and were twice as likely to developan infection in the limb as compared to survivors with-out lymphedema [8].At present, there are no known curative treatments,either surgical or pharmacological, for lymphedema [9].Rehabilitative treatments, also called conservative treat-ments, are prescribed to reduce and maintain limb size,to restore function, to reduce pain, and to improve theappearance of the limb [9, 10]. An initial intensive treat-ment program is usually prescribed to reduce the lymph-edema (Phase I) and is followed by a maintenance phase(Phase II) which aims to promote life-long maintenance[11]. Decongestive Lymphatic Therapy (DLT) is a 2-to-4 week intensive treatment program comprised of dailymanual lymph drainage (MLD) massage (a specializedmassage technique), wrapping with multi-layered short-stretch compression bandages (worn 23 h per day), ex-ercise, and education [12]. The current recommendedintensive treatment approach for Phase I is DLT, withor without the inclusion of the MLD massage compo-nent [9]. Following treatment to reduce the swelling, acompression sleeve is prescribed. Compression sleevesrepresent current standard of care in lymphedemamaintenance (Phase II) [9].A prospective cohort study including 682 women withbreast cancer related lymphedema examined the abilityof women to maintain arm lymphedema volume followingan intensive course of reduction treatment for lymph-edema [13]. In the study, the authors observed a gradualincrease in lymphedema volume over time among studyparticipants, with the greatest increases seen in the firstyear. The risk of treatment failure, defined as a >50 %relapse in arm lymphedema volume from baseline levels,was 38.1 %, 53.1 %, and 64.8 % at 1, 2, and 4 years respect-ively [13]. Interestingly, women who wore a day-timecompression sleeve and also wrapped their affected limbswith compression bandages (CB) at night (a minimum of4 nights per week), had a significantly reduced risk ofrelapse in arm lymphedema volume [hazard ratio, 0.53,(0.34–0.82), P = 0.004] [13]. The authors concluded thatsuccessful control of lymphedema may be dependent onthe combined use of the compression sleeve and CBduring day and night periods, respectively.Applying compression at night is an option that is usuallypresented to the survivor when the condition is advancedor when relapses in symptoms and/or arm lymphedemavolume occur [9]. When night-time compression is indi-cated, the survivor is taught how to apply the bandages tothe arm [Fig. 1]. Although many survivors are able tobandage their arm independently, a family member orsignificant other is often taught the bandaging tech-nique and assists the survivor at night. Various types ofnight-time compression system garments (NCSGs) havebeen designed as alternatives to CB. NCSGs are simpleFig. 1 Compression bandagingMcNeely et al. BMC Cancer  (2016) 16:601 Page 2 of 9to use, quick to apply to the limb, and can be easilyadjusted to provide the appropriate amount of pressure.In general, these compression system garments applygentle gradient pressure to the limb through a garmentwith a foam liner and a series of adjustable straps[Fig. 2]. The garments are non-elastic and provide lowresting pressure on the limb, making them safe to wearwhile sleeping at night. NCSGs provide an alternativeself-management strategy for women to reduce thetime burden associated with compression bandaging aswell as for those unable to appropriately apply CB totheir arm (e.g., older individuals with mobility issuesand/or those who live alone). Although NCSGs arealready available for purchase, as with many marketedtreatment options for lymphedema, little is knownabout their effectiveness.Hypotheses of randomized controlled trial (Phase I)1. Standard care plus the addition of CB will providestatistically significant improved management ofarm lymphedema volume compared to standardcare alone at 12-weeks.2. Standard care plus the addition of NCSG willprovide statistically significant improvedmanagement of arm lymphedema volumecompared to standard care alone at 12-weeks.3. Standard care plus the addition of NCSG willprovide statistically significant benefit in quality oflife, sleep and self-efficacy over standard care plusCB and standard care alone at 12-weeks.ObjectivesThe primary objectives of the randomized controlledphase of the trial are to determine the effect of night-time compression on arm lymphedema volume mainten-ance and quality of life in breast cancer survivors whohave completed intensive reduction treatment for theirlymphedema. These questions are seen as valuable forinforming implementation of night-time compression asa self-management strategy for lymphedema in the clin-ical setting. The primary objectives of follow-up are toevaluate the long-term adherence to use of night-timecompression and the timing of the intervention effect.As well, this follow-up period will allow us to betterunderstand who may benefit the most (or least) fromthe addition of night-time compression.Methods/DesignThe study will be a parallel 3-arm, multi-centre random-ized fast-track trial including the Cross Cancer Institute(CCI) in Edmonton, Tom Baker Cancer Centre (TBCC)in Calgary and Mount St. Joseph’s Hospital (MSJ) inVancouver. Women enrolled in the study will be stratifiedby accruing centre (CCI, TBCC, MSJ) and by lymphedemaseverity (i.e., mild versus moderate lymphedema as per theclassification criteria of International Society of Lymphol-ogy) [9, 14], and then randomly assigned to one of threegroups: (1) standard care (day-time use of a compressionsleeve alone); (2) standard care plus night-time compres-sion by self-administered or assisted CB; (3) standardcare plus night-time compression by a traditional NCSG.The duration of the primary intervention period will be12 weeks. Results from the pilot study and previous casestudies suggest a small initial reduction in arm lymph-edema volume from administration of the traditionalstrapped NCSG over the first 6 weeks with stabilization ofarm volume (plateau) occurring thereafter. Thus, the12-week intervention period is deemed sufficient to ob-serve an intervention effect and was chosen to alignwith current clinical follow-up time periods. Followingthe 12-week intervention period, participants in the CBand standard care groups will be measured for a NCSG.Participants in these two groups will follow the proto-col as per the NCSG group during weeks 13 to 24[Fig. 3].The randomized fast-track trial (with delayed assign-ment to NCSG for both comparison groups) is seen as amore acceptable design to patients, families and staff,Fig. 2 Example of strapped version of a night-time compressionsystem garmentMcNeely et al. BMC Cancer  (2016) 16:601 Page 3 of 9given that the majority of eligible participants will have astrong preference for assignment to the NCSG group.Moreover, we feel this design, which was used in thepilot study, will optimize recruitment and retention ofthe comparison group participants in the trial.The follow-up period after the intervention (weeks 13to 24) will follow a longitudinal observational design andprovides an opportunity to examine factors related long-term adherence to night-time compression.ParticipantsThe following eligibility criteria will be used to determineparticipant inclusion in the trial:1. Women with a histological diagnosis of breastcancer experiencing lymphedema in the ipsilateralarm such that there is a minimum 200 ml or 10 %,and maximum 40 % increase in arm volume overthe unaffected arm (indicative of mild to moderatelymphedema) [14].2. Survivors must have completed all primary andadjuvant cancer treatments (with the exception ofhormonal treatment) by a minimum of 1 monthprior to randomization.3. Survivors must be in or entering the lymphedemamaintenance phase and agreeable to not pursuing anyother lymphedema maintenance treatments beyondday-time use of a compression sleeve.4. Survivors must have their own properly fittedcompression sleeve for day-time maintenanceand must agree to wear their day-time sleeve asper standard care for a minimum of 12 h perday.5. No current use of night-time compression formaintenance. Any survivor who has trialed aNCSG/performed night-time CB in the past year formaintenance purposes must observe a one-monthwashout period before entering the trial.Survivors will be excluded if they present with any of thefollowing1. Clinical or radiological evidence of active breastcancer, either local or metastatic.2. History and clinical diagnosis of bilateral armlymphedema.3. Serious non-malignant disease, such as renal orcardiac failure, which would preclude dailytreatment and follow-up.4. Survivors for whom compression is contraindicated,such as those with untreated infections, skinirritation/rash or thromboses in the affected arm.5. Psychiatric or addictive disorders, as determined bythe referring physician, which preclude obtaininginformed consent or adherence to the protocol.6. Unable to comply with the protocol, measurement,and follow-up schedule due to factors, such asvacation during the study period.InterventionsManagement in both the experimental and comparisongroups will follow recommendations of the CanadianFig. 3 Study schemaMcNeely et al. BMC Cancer  (2016) 16:601 Page 4 of 9Breast Cancer Initiative’s Steering Committee for ClinicalPractice Guidelines for the Care and Treatment of BreastCancer [15]. Survivors will be provided with advice con-cerning good skin care, regular exercise, maintenance of ahealthy body weight, and the use of a day-time compres-sion sleeve.Group 1: standard care: day-time use of compression sleevealoneWomen randomized to the standard care group willreceive standard care for lymphedema maintenance. Inthis group of the trial, each participant will be instructedto wear their day-time compression sleeve with or with-out a gauntlet/glove (worn if swelling in the hand andfingers), providing a minimum of 30 mm Hg of pressure,for 12 h per day, each day of the week. A 6-week follow-up will be performed to evaluate response and adherenceto the standard care protocol. At week 12, women in thisarm of the trial will be fitted for a NCSG and will followthe protocol outlined in the experimental arm of the trial.Group 2: standard care plus night-time multi-layeredCompression Bandaging (CB group)Women randomized to the night-time CB group will beinstructed in the application of night-time multi-layeredCB by the physical therapist. Women who have per-formed nighttime multi-layered CB as part of their pastmaintenance program will attend a review session to en-sure appropriate bandaging technique and application.Educational materials related to compression bandagingapplication will be provided. Participants will have a2-week phase in period, following which they will beasked to wear the CB at night while sleeping for aminimum of 8 h per night, a minimum of five nightsper week for 4 weeks (weeks 3–6). As per standard ofcare, each participant will be required to wear theirday-time compression sleeve with or without a gauntlet/glove, providing a minimum of 30 mm Hg of pressure, for12 h per day, each day of the week. A 6-week follow-upwill be performed to evaluate response and adherence tothe CB protocol. At that point, maintenance CB a mini-mum of 3 times per week will be introduced. At week 12,women in this arm of the trial will be fitted for a NCSGand will follow the protocol outlined in the experimentalarm of the trial.Group 3: standard care plus Night-Time CompressionSystem Garment (NCSG group)Women randomized to the immediate NCSG group willbe measured for a NCSG. Once the garment has arrived,participants in this group will be instructed in use oftheir NCSG by the physical therapist. Educational mate-rials related to garment application and maintenance willbe provided. Participants will have a 2-week phase inperiod, following which they will be asked to wear theNCSG at night while sleeping for a minimum of 8 h pernight, a minimum of five nights per week for 4 weeks(weeks 3–6). As per standard of care, each participantwill be required to wear their day-time compression sleevewith or without a glove/gauntlet, providing a minimum of30 mm Hg of pressure, for 12 h per day, each day of theweek. A 6-week follow-up will be performed to evaluateresponse, adherence to the protocol and to address anyissues with wear of the NCSG. At that point, maintenanceNCSG a minimum of 3 nights per week will be intro-duced. After the 12-week assessment, participants in thisarm of the trial will have the option to continue use oftheir NCSG.RecruitmentEthics approval and signed informed consent of partici-pants is required. Recruitment started after approval wasreceived from all respective Health Research EthicsCommittees (Health Research Ethics Board of Alberta:Cancer Committee and the University of British ColumbiaEthics Board). The estimated timeline for recruitment is18–24 months. Potential participants will be identifiedand screened for eligibility by the respective research coor-dinators through the Rehabilitation Medicine Depart-ments at the CCI in Edmonton, the TBCC in Calgary, andMSJ in Vancouver. Initial eligibility will be determined bychart review and, if necessary, verified through contactwith the participant’s physician. Interested participantswill be scheduled for a baseline visit to obtain writtenconsent and for final determination of eligibility. It isanticipated that 10 to 15 breast cancer survivors withlymphedema (per month) will be eligible among the threecentres and that 5–8 women (per month) will agree toparticipate. Follow-up measurements will occur at week 6,12 (end of RCT portion), 18, and 24 following the start ofthe assigned intervention for the participant. The lastparticipant entering the trial will therefore undergo her24-week follow-up measurement approximately 30 monthsafter recruitment begins.Baseline data and endpointsDuring the baseline visit, demographic and clinical infor-mation will be collected on participants. Medical datawill be abstracted from the medical health records.Primary endpointsArm volume is a commonly used metric to evaluatelymphedema severity and to inform decision-making inthe clinical setting. Lymphedema will be objectivelymeasured using the Perometer (Pero-systems, Wipputal,Germany). The Perometer is an optoelectric limb volume-ter that uses infrared technology to quantify limb volumeand determine inter-limb difference. Measurement withMcNeely et al. BMC Cancer  (2016) 16:601 Page 5 of 9the perometer takes approximately 3 min to complete.The perometer is a valid, reliable, and sensitive methodfor quantifying limb volume [16–18].Quality of life will be measured using the condition-specific Lymphoedema Functioning, Disability and HealthQuestionnaire (Lymph-ICF) [19]. This 29-item question-naire was developed to assess quality of life specific tolymphedema and to monitor progress of treatment onfunction (i.e., movement, activities) and symptoms relatedto lymphedema (i.e., pain, discomfort, heaviness, and ten-sion) as well as to assess activity limitations and participa-tion restrictions. The Lymph-ICF has been tested andshown to be valid and reliable [19]. As well, generalhealth-related quality of life will be assessed at each visitby using the RAND 36-item Short Form Health Survey(SF-36). These two questionnaires will take approximately10–15 min to complete.Secondary endpointsSecondary endpoints will include bioimpedance analysis,adherence, sleep disturbance, and self-efficacy.Bioimpedance analysis (BIA) will be used to assessextracellular fluid status within the arm. BIA measuresthe impedance of flow from a low alternating electricalcurrent that is applied to the body through a skin elec-trode. BIA records impedance values for each limb andprovides an index that correlates with quantitative mea-surements of volume increase in limb size seen in thearm with lymphedema [20]. BIA is a simple, painlessprocedure that takes less than 5 min to perform. BIAhas been shown to be a more sensitive measure thanarm volume in detecting changes in lymphedema inthose with early mild lymphedema but less reliable inthose with long-standing lymphedema [20]. This meas-urement will provide information on extracellular fluidchanges that complements the data on arm lymphedemavolume.Sleep disturbance will be assessed using the RANDMedical Outcomes Survey Sleep Survey [21]. The surveymeasures 6 key dimensions of sleep: sleep initiation,maintenance, quantity, adequacy, drowsiness, and respira-tory impairments (e.g. shortness of breath, snoring). Thesleep scale will be used to assess the impact, if any, ofwearing night-time compression on sleep quality. Thequestionnaire takes 5 min to complete.Self-efficacy of lymphedema managementSelf-efficacy will be assessed based on the 6-item ChronicDisease Self-Management scale [22] modified for use withlymphedema. The scale assesses several domains that arecommon across chronic diseases such as symptom control,role function, emotional functioning, and communicatingwith physicians. The questionnaire takes 3-to-5 min tocomplete.Body height will be recorded at baseline and bodyweight at baseline and each follow-up time point.AdherenceParticipants will be asked to record their adherence (i.e.days per week, hours per day) to their assigned compres-sion therapy treatment in a daily journal. Treatment-specific outcomes such as the time required for adminis-tration of night-time compression, reasons for removalof the garment at night and independence/assistance inapplication will be included in the diary. Participants willbe asked to return the completed diary for each respective6-week time period at the subsequent follow-up visit. Wewill also record any additional appointments required toteach CB or to assess wear/fit of the NCSG.Adverse eventsAdverse events related to the application of compression(i.e. skin breakdown or reaction, such as rash) will berecorded. Any adverse events related to the condition oflymphedema (i.e. infection/cellulitis or blood clot in thearm) will be verified with the participant’s physician. Ifthis occurs, as per standard care, treatment with com-pression will be stopped until deemed safe to resume bythe physician. We will also record any relapses in armlymphedema volume (>50 %) that require more intensivereduction treatment.Allocation concealment and method of randomizationParticipants will be randomized in a 1:1:1 ratio to StandardCare, CB or NCSG using a secure central randomizationservice administered by the Clinical Trials Unit of the CrossCancer Institute.BlindingAt each measurement point starting after the baselineassessment through the RCT portion of the trial (i.e.,6 week and 12 week follow-ups), an Independent Assessorunaware of treatment allocation (blinded) will perform themeasurements of arm volume using the perometer, bioim-pedance analysis, and body weight. The IndependentAssessor will also administer the outcome measures forsleep disturbance, self-efficacy, and quality of life. TheAdherence Diary will be collected by the Research Coord-inator at each follow-up visit. Follow-up sessions will takeplace in the respective rehabilitation department and eachsession will take 30 to 45 min to complete. Blinding ofparticipants and practitioners will not be possible as par-ticipants are aware of the compression therapy treatmentthey are receiving. Study garments will be purchased atcost from participating industry partners through thegrant funds. In the event that a study participant is unableto continue with their assigned treatment, they will re-main in their randomized group to preserve the intention-McNeely et al. BMC Cancer  (2016) 16:601 Page 6 of 9to-treat principle. Study participants will be free to with-draw at any time but will be invited to continue to attendfor scheduled follow-ups for the duration of the study.Sample size for randomized fast-track trial phaseThe sample size required per group to detect at least aminimal clinically important mean difference of 20 %(SD ±25) in arm lymphedema volume in favor of eitherthe standard care + NCSG, standard care + CB groupand standard care alone is 36 participants. A total sam-ple of 108 participants will achieve a power of 86 % witha significance level of 0.05 using a one way ANOVA test.The sample size required per group to detect at least aminimal clinically important difference on the Lymph-ICF quality of life scale of 15 points out of 100 (SD ±22)between the standard care + CB group and the standardcare + NCSG group is 36 participants. A total sample of108 will achieve a power of 80 % with a significance levelof 0.05 using a two-sided Mann-Whitney test assumingthe actual distribution is normal. To allow for an estimated10 % loss to follow-up and non-compliance/cross-over ofthe standard care group, we will recruit an additional 12patients for a total of 120 participants (40 participants ineach of the three treatment groups).Statistical analysesBaseline medical and demographic characteristics, armdominance relative to the lymphadematous arm, andadverse events of the three groups will be comparedusing one-way ANOVA for continuous data and Pear-son’s Chi-square tests for categorical data. The primaryanalysis will compare the groups with regard to percentexcess lymphedema volume and quality of life at 12-weeks using a one-way ANOVA. General linear modelswill be used to adjust for centre and lymphedema cat-egory (mild or moderate), and to evaluate the treatmenteffect in subgroups defined by the strata. Sleep quality,self-efficacy, and adherence-related outcomes will beanalyzed by repeated measures modeling and one-wayANOVA on change scores.Descriptive data on accrual rates will include the num-ber of women screened for eligibility, the number eligible,the number agreeing to participate, and reasons for refusalto participate. Data on adherence will be collected fromall women throughout the 24-week study period. Adher-ence data will include days worn per week and hours wornper 24-h period, as appropriate, for each of the following:1) NCSG; 2) CB; 3) day-time compression sleeve. We willalso examine adherence during weeks 13 to 24 to thenewly assigned NCSG for the standard care and standardcare + CB groups, and ongoing adherence during weeks13 to 24 in the originally assigned standard care +NCSGgroup. Analyses of primary outcomes will be performed atthe end of the RCT portion of the trial. Within groupanalyses will also be conducted for primary and secondaryoutcomes from weeks 13 to 24 following completion of allfollow-up measures.Trial managementA primary Trial Coordinator will be assigned by theCTU for the Edmonton site and this individual will over-see the day-to-day operations of the project and reportdirectly to Dr. McNeely. The primary Trial Coordinatorrevised the standard operating procedures used in thepilot study in consultation and in collaboration with theresearch team members. The Calgary and Vancouver siteshave Research Coordinators/Physical Therapist (PT) whowork under the supervision of Drs. McNeely and Campbell,respectively. The respective Research Coordinator-PT willbe responsible for booking of participant appointments,teaching of self-bandaging to participants, measurementand fitting of participants for night-time compression sys-tem garments, and provide assistance and oversight for datacollection and data entry. Case report form development,randomization, data entry, quality assurance and data ana-lysis will be carried out by the CTU. To protect the identityof study participants, forms will be labeled with the partici-pant study identification number and initials only. Originalcase report forms will be sent to the CTU. Copies of theoriginal forms will be secured in the respective depart-ments. The CTU will provide biostatistical support for thestatistical analyses of data.DiscussionIntegrated knowledge translationA survivor-representative, physical and occupational thera-pists, rehabilitation department administrators, and indus-try were asked to provide input on knowledge translationgoals and methods. Consumer interests include informa-tion on the value of the garment for lymphedema, garmentchoice and options and prescription variables (i.e. howlong to wear, how many nights per week). Goals of thehealthcare practitioners include understanding the rela-tive benefit of NCSGs and resolving when to best prescribegarments. Other questions revolve around independencein application and time benefit for the survivor. In-dustry interests include questions on NCSG comfortand effectiveness.Knowledge translation methods will include webinars,workshops and small group face-to-face sessions for sur-vivor groups in Alberta and British Columbia as well asfront-line health care practitioners working directly withbreast cancer survivors in these two provinces. Connec-tions with Alberta’s Community Cancer Support Network,Alberta CancerControl Supportive Care Council, BritishColumbia Cancer Agency, the Alberta Lymphedema As-sociation and the British Columbia Lymphedema Associ-ation will ensure that information gained from the studyMcNeely et al. BMC Cancer  (2016) 16:601 Page 7 of 9will be delivered across the regions (i.e, newsletter andemail communications). Nationally, research findingswill be disseminated to the Canadian Physiotherapy As-sociation Oncology Division (i.e. study briefing in news-letter), and the Canadian Lymphedema Framework (i.e.,lay language summary in lymphedema magazinePathways).LimitationsLimitations of the current design include the requirementthat participants be able and willing to be randomized toone of the three groups for a 12-week period. For thisreason, we anticipate women who regularly administer CBat night and/or attend regular maintenance sessions ofMLD will not be interested, or eligible to take part in thetrial.Progress to dateAs of September 2015, 39 women with breast cancerrelated lymphedema have been randomized and noadverse events have occurred.Relevance and innovationAs the numbers of survivors of breast cancer continuesto grow, there is need for supportive care interventionsto address the late and long-term effects of cancer treat-ment. Lymphedema is a prevalent long-term effect oftreatment that is associated with reduced quality of life.There are currently a number of products and deviceson the market purported to reduce and/or help managelymphedema, many of which can be purchased directlyby the survivor on the internet. However, there is a paucityof quality research to support the use of many of theseproducts and interventions for lymphedema, includingNCSGs. For these reasons, healthcare practitioners areunsure of how to best advise survivors. This study willprospectively examine the effect of the addition of night-time compression to current standard care on the qualityof life of breast cancer survivors with lymphedema. Whilethese treatment techniques have been used clinically formany years, the evolution of night-time compression ther-apy as a self-management strategy is the innovative aspectof this approach and research. In this way, this study willhelp advance the knowledge on self-management strat-egies for lymphedema.AcknowledgementsWe thank the Alberta Cancer Foundation and Canadian Institutes of HealthResearch for their financial support and the survivors who are taking part orwill take part in the study.FundingThe Alberta Cancer Foundation and the Canadian Institutes of HealthResearch are supporting this research.Availability of data and materialsThe data supporting future findings can be requested from Dr. MargaretMcNeely.Authors’ contributionsAll authors contributed to the study idea and design. MLM developed theoverall study methods and drafted the manuscript. KLC, UK, MW, KT and JMdeveloped the study methods for the respective centres. MLM, KLC, UK, MW,KT and JM will be responsible for survivor recruitment and data acquisition.All authors edited, read and approved the final manuscript.Competing interestsThe authors declare that they have no competing interests.Consent for publicationNot applicable.Ethics approval and consent to participateThe trial was registered with clinicaltrials.gov on July 9th, 2014 prior to studyinitiation. Ethics approval and signed informed consent of participants isrequired.The Health Research Ethics Board of Alberta: Cancer Committee approvedthis study on October 17th 2014.Author details1Department of Physical Therapy, University of Alberta & Cross CancerInstitute, 2-50 Corbett Hall, Edmonton, Alberta T6G 2G4, Canada.2Department of Physical Therapy, University of British Columbia, Vancouver,British Columbia, Canada. 3Medical Oncology, Tom Baker Cancer Centre,Alberta Health Services & Department of Oncology, University of Calgary,Calgary, Alberta, Canada. 4Department of Surgery, Faculty of Medicine,University of British Columbia & British Columbia Cancer Agency, Vancouver,British Columbia, Canada. 5Clinical Trials Unit, Cross Cancer Institute, AlbertaHealth Services, Edmonton, Alberta, Canada. 6Medical Oncology, CrossCancer Institute, Alberta Health Services & Department of Oncology,University of Alberta, Edmonton, Alberta, Canada.Received: 5 October 2015 Accepted: 28 July 2016References1. 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A prospective model of care for breast cancer rehabilitation:function. Cancer. 2012;118(8 Suppl):2300–11.7. Paskett ED, Dean JA, Oliveri JM, Harrop JP. Cancer-related lymphedemarisk factors, diagnosis, treatment, and impact: a review. J Clin Oncol.2012;30(30):3726–33.8. Shih YC, Xu Y, Cormier JN, Giordano S, Ridner SH, Buchholz TA, Perkins GH,Elting LS. Incidence, treatment costs, and complications of lymphedemaafter breast cancer among women of working age: a 2-year follow-upstudy. J Clin Oncol. 2009;27(12):2007–14.9. Framework L. Best practice for the management of lymphoedema: aninternational consensus. London: MEP Ltd; 2006. London: MEP Ltd; 2006.10. Armer JM. Lymphedema. In: Hassey Dow K, editor. Nursing Care of Womenwith Cancer. St. Louis: Mosby Elsevier; 2006. p. 204–25.11. Chang CJ, Cormier JN. Lymphedema interventions: exercise, surgery, andcompression devices. Semin Oncol Nurs. 2013;29(1):28–40.McNeely et al. BMC Cancer  (2016) 16:601 Page 8 of 912. Lasinski BB, McKillip Thrift K, Squire D, Austin MK, Smith KM, Wanchai A,Green JM, Stewart BR, Cormier JN, Armer JM. A systematic review of theevidence for complete decongestive therapy in the treatment oflymphedema from 2004 to 2011. PM R. 2012;4(8):580–601.13. Vignes S, Porcher R, Arrault M, Dupuy A. Factors influencing breastcancer-related lymphedema volume after intensive decongestivephysiotherapy. Support Care Cancer. 2011;19(7):935–40.14. International Society of Lymphology. Consensus document of theInternational Society of Lymphology. Lymphology. 2003;36(2):84–91.15. Harris SR, Hugi MR, Olivotto IA, Levine M. Clinical practice guidelinesfor the care and treatment of breast cancer: 11. Lymphedema. CMAJ.2001;164(2):191–9.16. Stanton AW, Northfield JW, Holroyd B, Mortimer PS, Levick JR.Validation of an optoelectronic limb volumeter (Perometer).Lymphology. 1997;30(2):77–97.17. Armer JM, Stewart BR. A comparison of four diagnostic criteria forlymphedema in a post-breast cancer population. Lymphat Res Biol.2005;3(4):208–17.18. Ancukiewicz M, Russell TA, Otoole J, Specht M, Singer M, Kelada A, MurphyCD, Pogachar J, Gioioso V, Patel M, et al. Standardized method forquantification of developing lymphedema in patients treated for breastcancer. Int J Radiat Oncol Biol Phys. 2011;79(5):1436–43.19. Devoogdt N, Van Kampen M, Geraerts I, Coremans T, Christiaens MR.Lymphoedema Functioning, Disability and Health questionnaire(Lymph-ICF): reliability and validity. Phys Ther. 2011;91(6):944–57.20. Ward LC, Czerniec S, Kilbreath SL. Quantitative bioimpedancespectroscopy for the assessment of lymphoedema. Breast Cancer ResTreat. 2009;117(3):541–7.21. Hays RD, Martin SA, Sesti AM, Spritzer KL. Psychometric properties of theMedical Outcomes Study Sleep measure. Sleep Med. 2005;6(1):41–4.22. Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract.2001;4(6):256–62.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services •  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submitSubmit your next manuscript to BioMed Central and we will help you at every step:McNeely et al. BMC Cancer  (2016) 16:601 Page 9 of 9


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