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Randomized Controlled Trial
Decision Coaching for Healthy Women With BRCA1/2 Pathogenic Variants—Findings of the Randomized Controlled EDCP-BRCA Trial.
- Stephanie Stock, Anna Isselhard, Arim Shukri, Sibylle Kautz-Freimuth, Marcus Redaèlli, Birte Berger-Höger, Nicola Dikow, Marion Kiechle, Juliane Köberlein-Neu, Cornelia Meisel, Rita Schmutzler, Anke Steckelberg, Marion Tina van Mackelenbergh, Frank Vitinius, Achim Wöckel, and Kerstin Rhiem.
- Dtsch Arztebl Int. 2024 Jun 14 (Forthcoming).
BackgroundWomen with BRCA1/2 pathogenic variants (PVs) have a choice of preventive options. To help these women decide for themselves, we developed and implemented a decision coaching (DC) program and evaluated it for congruence between the participants' desired and actual roles in decision-making.MethodsHealthy BRCA1/2 PV carriers (from 25 to 60 years of age) were recruited at six centers in Germany. Those returning baseline T1-questionnaires were randomly assigned to the intervention group (IG) or the control group (CG). The IG attended a nurse-led DC program. The primary outcome was congruence between the participants' desired and actual roles in decision-making. The secondary outcomes included an active role, satisfaction, decisional conflict, and knowledge. Follow-up data were obtained by questionnaire at 12 weeks (T2) and 6 months (T3).ResultsOf the 413 women who were recruited, 389 returned baseline T1 questionnaires. At T2, the IG and CG groups did not differ significantly in congruence between their desired and actual roles in decision-making (0.12 [95% confidence interval -0.03; 0.28], p=0.128), with a slightly higher congruence in the CG. Women in both groups were more active at T2 than their stated preference at T1, with a notably higher percentage in the IG (IG: 40%, CG: 24.4%; [-25.1; -6.1]). IG participants were more satisfied with the role that they had assumed and had less decisional conflict and greater knowledge.ConclusionThese findings imply that this DC program can help women with BRCA1/2 PVs participate actively in decision-making with regard to preventive measures.
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