Abstract
BackgroundWomen 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.MethodsA 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.DiscussionThese will be the first decision aids available for BRCA1/2 mutation carriers in Germany to be evaluated regarding their effectiveness and acceptability in clinical use within an RCT. Subsequently, they are to be integrated into the care concept of the centres of the German Consortium for Hereditary Breast and Ovarian Cancer and the affiliated breast centres.Trial registration {2a}DRKS DRKS00015823. Retrospectively registered on 14 June 2019
Highlights
Background and rationale {6a} Women with a pathogenic germline mutation in the BRCA1 or BRCA2 gene face a high risk of developing breast cancer (BC) and ovarian cancer (OC)
The analysis showed that decision aids (DAs) support these women most likely by improving decision-related outcomes: Women who received a DA experienced lower decisional conflict were more likely to come to a decision and were more satisfied with the decision made compared to women who did not receive a DA [37]
Objectives {7} The aim of this study is to evaluate two newly developed evidence-based DAs for women with pathogenic BReast CAncer genes 1 and 2 (BRCA1/2) mutations in Germany with regard to their effectiveness on decision, psychological- and knowledge-related factors in clinical use and their acceptability with the addressees
Summary
Background and rationale {6a} Women with a pathogenic germline mutation in the BRCA1 or BRCA2 gene face a high risk of developing breast cancer (BC) and ovarian cancer (OC). Diagnosed BRCA1/2 mutation carriers are offered various preventive options to counter their increased cancer risks These include an intensified breast cancer screening programme for previvors or an intensified breast cancer screening and aftercare programme for survivors and risk-reducing surgeries of the breasts and the adnexa for both groups. 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
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
