Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial
department or school: Medicine, Faculty of
department or school: Non UBC
department or school: Population and Public Health (SPPH), School of
data provider: DSpace
identifier citation: Trials. 2022 Feb 16;23(1):157
rights copyright: The Author(s)
creator: Kautz-Freimuth, Sibylle
creator: Redaèlli, Marcus
creator: Isselhard, Anna
creator: Shukri, Arim
creator: Vodermaier, Andrea
creator: Rhiem, Kerstin
creator: Schmutzler, Rita
creator: Stock, Stephanie
issued: 2022-03-11T17:54:46Z
issued: 2022-02-16
description: Background Women with BRCA1/2 mutations have a higher risk of developing breast and ovarian cancer compared to women of the general population. Various preventive options are available to deal with the increased risk of developing cancer. These include intensified breast cancer screening and risk-reducing bilateral mastectomy and salpingo-oophorectomy. The choice of a preventive option can lead to increased decisional conflict. To support these women in their decision-making process, two evidence-based decision aids were developed in an upstream research process and adapted to the German healthcare context. These will be evaluated within a randomised controlled trial (RCT) in terms of their effects on decision-making, women’s level of information and psychological outcome variables. Methods A sample of 310 women carrying BRCA1/2 mutations (A) without a history of cancer or (B) with a history of unilateral breast cancer who have received post-test genetic counselling will be enrolled. Upon study consent, women will be randomly assigned to either the intervention or the control group. All participants will receive standard care including a physician’s letter summarising the counselling content. After baseline data collection (t0), the intervention group receives the respective decision aid while the control group receives standard care only. The primary outcome variable assessed at a 3-month follow-up (t1) is the change of extent in decisional conflict (measured with the Decisional Conflict Scale). Secondary outcome variables comprise the stage of decision-making, self-reported symptoms of anxiety, depression and stress due to the genetic test result, and knowledge regarding cancer risks and preventive options. At t1, the extent of preparation for decision-making and acceptability of the decision aids will also be examined. Another secondary outcome variable assessed at 6-month follow-up (t2) is the extent of decision regret. Discussion These will be the first decisio…
aggregated CHO: https://circle.library.ubc.ca/rest/handle/2429/80944
note: STUDY PROTOCOL Open AccessEvaluation of two evidence-based decisionaids for female BRCA1/2 mutation carriersin Germany: study protocol for arandomised controlled parallel-group trialSibylle Kautz-Freimuth1* , Marcus Redaèlli1, Anna Isselhard1, Arim Shukri1, Andrea Vodermaier1,2, Kerstin Rhiem3,Rita Schmutzler3 and Stephanie Stock1AbstractBackground: Women with BRCA1/2 mutations have a higher risk of developing breast and ovarian cancercompared to women of the general population. Various preventive options are available to deal with the increasedrisk of developing cancer. These include intensified breast cancer screening and risk-reducing bilateral mastectomyand salpingo-oophorectomy. The choice of a preventive option can lead to increased decisional conflict. To supportthese women in their decision-making process, two evidence-based decision aids were developed in an upstreamresearch process and adapted to the German healthcare context. These will be evaluated within a randomisedcontrolled trial (RCT) in terms of their effects on decision-making, women’s level of information and psychologicaloutcome variables.Methods: A sample of 310 women carrying BRCA1/2 mutations (A) without a history of cancer or (B) with a historyof unilateral breast cancer who have received post-test genetic counselling will be enrolled. Upon study consent,women will be randomly assigned to either the intervention or the control group. All participants will receivestandard care including a physician’s letter summarising the counselling content. After baseline data collection (t0),the intervention group receives the respective decision aid while the control group receives standard care only. Theprimary outcome variable assessed at a 3-month follow-up (t1) is the change of extent in decisional conflict(measured with the Decisional Conflict Scale). Secondary outcome variables comprise the stage of decision-making,self-reported symptoms of anxiety, depression and stress due to the genetic test res…
has type: Article
is shown at: 10.14288/1.0407134
language: eng
peer review status: Reviewed
provider: Vancouver : University of British Columbia Library
publisher: BioMed Central
publisher DOI: 10.1186/s13063-022-06081-7
rights: Attribution 4.0 International (CC BY 4.0)
rights URI: http://creativecommons.org/licenses/by/4.0/
scholar level: Faculty
scholar level: Researcher
scholar level: Other
subject: BRCA1 mutation
subject: BRCA2 mutation
subject: Decision aid
subject: Decision-making
subject: Evaluation study
subject: Familial breast and ovarian cancer
subject: Hereditary breast and ovarian cancer (HBOC)
subject: Preventive measures
subject: Preference-sensitive decisions
subject: Patient-centred care
type: Text
identifier URI: http://hdl.handle.net/2429/80944