Institute of Health Economics and Clinical Epidemiology, The University Hospital of Cologne, Gleueler Straße 176-178, 50935, Cologne, Germany.
School of Population and Public Health, The University of British Columbia, 2206 East Mall, Vancouver, BC, C6T 1Z3, Canada.
Trials. 2022 Feb 16;23(1):157. doi: 10.1186/s13063-022-06081-7.
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.
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.
These 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.
与普通人群相比，携带 BRCA1/2 突变的女性患乳腺癌和卵巢癌的风险更高。有各种预防措施可以应对癌症风险的增加。这些措施包括加强乳腺癌筛查和降低风险的双侧乳房切除术和输卵管卵巢切除术。选择预防措施可能会导致决策冲突加剧。为了在决策过程中为这些女性提供支持，在一个上游研究过程中开发了两种基于证据的决策辅助工具，并适应了德国的医疗保健环境。这些将在一项随机对照试验 (RCT) 中进行评估，以评估它们对决策、女性信息水平和心理结果变量的影响。
将招募 310 名携带 BRCA1/2 突变（A）且无癌症史或（B）单侧乳腺癌病史且已接受过检测后遗传咨询的女性。在获得研究同意后，女性将被随机分配到干预组或对照组。所有参与者将接受标准护理，包括医生的信，总结咨询内容。基线数据收集后（t0），干预组接受相应的决策辅助工具，而对照组仅接受标准护理。3 个月随访时（t1）评估的主要结局变量是决策冲突程度的变化（用决策冲突量表测量）。次要结局变量包括决策阶段、因基因检测结果而出现的焦虑、抑郁和压力的自我报告症状，以及对癌症风险和预防措施的知识。在 t1 时，还将检查决策准备程度和决策辅助工具的可接受性。另一个在 6 个月随访时（t2）评估的次要结局变量是决策后悔的程度。
这将是德国首批针对 BRCA1/2 突变携带者的决策辅助工具，将在 RCT 中评估其在临床使用中的有效性和可接受性。随后，它们将被纳入德国遗传性乳腺癌和卵巢癌联合会和附属乳房中心的护理概念中。
[2A]DRKS DRKS00015823。2019 年 6 月 14 日回顾性注册。
