Sibylle Kautz-Freimuth

Decisional conflict and knowledge in women with BRCA1/2 pathogenic variants: An exploratory age group analysis of a randomised controlled decision aid trial

Female BRCA1/2 pathogenic variant (PV) carriers face substantial risks for breast and ovarian cancer. Evidence-based decision aids (DAs) can facilitate these women in their decision-making process on an individually suitable preventive strategy. However, there is a gap in previous literature exploring whether DA effectiveness varies according to women’s age. This is an exploratory subanalysis with a descriptive approach from a randomised controlled study assessing the effectiveness of a German decision aid (DA) for women with BRCA1/2 PVs compared to no DA use. From the original sample, women aged 18–40 years and >40 years and the intervention and control groups (IG, CG) within each of the age groups were compared regarding decisional conflict (using the Decisional Conflict Scale DCS) and knowledge at baseline and after DA use three and six months post study inclusion. The subanalysis involved 236 women aged 18–40 and 181 women aged >40 years. At baseline, both age groups differed significantly in all socio-demographic variables, except BRCA1/2 PV distributions. The younger age group displayed higher scores in the DCS subscale informed (p = .002) and higher knowledge (p = .010). Among the 18-40-year-olds, DA use (versus no DA) led to improvements in the DCS subscale informed at three (p = .025) and six months (p = .000). In the >40-year-olds, DA use (versus no DA) led to improvements in the DCS subscales informed (p = .028), values clarity (p = .028) and support (p = .030) and increased knowledge at three months (p = .048). These results indicate that both age groups benefited from DA use, but the older ones did so to a greater extent. This suggests that it might be useful to tailor DAs more closely to age- or life stage-related needs to enable more personalised care and support for women with BRCA1/2 PVs.

Development of decision aids for female BRCA1 and BRCA2 mutation carriers in Germany to support preference-sensitive decision-making

AbstractBackgroundWomen with pathogenicBRCA1andBRCA2mutations possess a high risk of developing breast and ovarian cancer. They face difficult choices when considering preventive options. This study presents the development process of the first decision aids to support this complex decision-making process in the German healthcare system.MethodsA six-step development process based on the International Patient Decision Aid Standards was used, including a systematic literature review of existing decision aids, a topical medical literature review, preparation of the decision aids, focus group discussions with women withBRCA1/2mutations, internal and external reviews by clinical and self-help experts, and user tests. All reviews were followed by iterative revisions.ResultsNo existing decision aids were transferable to the German setting. The medical research revealed a need to develop separate decision aids for women withBRCA1/2mutations (A) without a history of cancer (previvors) and (B) with a history of unilateral breast cancer (survivors). The focus group discussions confirmed a high level of approval for the decision aids from both target groups. Additionally, previvors requested more information on risk-reducing breast surgery, risk-reducing removal of both ovaries and Fallopian tubes, and psychological aspects; survivors especially wanted more information on breast cancer on the affected side (e.g. biological parameters, treatment, and risk of recurrence).ConclusionsIn a structured process, two target-group-specific DAs for previvors/survivors withBRCA1/2mutations were developed to support decision-making on risk-adapted preventive options. These patient-oriented tools offer an important addition to existing specialist medical care in Germany.

Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial

Abstract 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 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