Objective: Women carrying a BRCA1/2 pathogenic variant have an increased risk for breast cancer and may opt for risk‐reducing bilateral mastectomy. In this study, we examine which demographic, psychosocial, and personality factors are associated with their decision to undergo risk‐reducing bilateral mastectomy.Methods: Cancer‐unaffected women with a pathogenic variant in BRCA1 or BRCA2 were recruited before receiving their genetic test result and completed follow‐up including decision to undergo mastectomy over 6–8 months after genetic test result disclosure. Anxiety, depression, breast cancer worry, personality and sociodemographic data were assessed.Results: A total of 125 cancer‐unaffected women were included in the analysis. Participants were found to have higher anxiety levels than the general female population regardless of mastectomy decision. Breast cancer worry was higher among women who opted for risk‐reducing mastectomy and did not decrease over time. By contrast, women who did not opt for surgery experienced decreasing levels of breast cancer worry. Regression analysis found that women with a pathogenic variant in BRCA1, younger women and women with higher breast cancer worry were more likely to opt for surgery.Conclusions: Our study provides valuable insights into the factors that influence women with a BRCA1/2 pathogenic variant to undergo risk‐reducing mastectomy. These findings may be helpful in understanding individual differences in decision‐making concerning preventive options and show the need to address negative anticipatory feelings associated with carrying a pathogenic variant in a high breast cancer risk gene in clinical care.

Background: Female BRCA mutation carriers have an increased lifetime risk for breast and ovarian cancer compared to the general population. Women who carry this mutation have several options to deal with their cancer risk, such as risk-reducing surgeries or intensified breast cancer screening. Previous research has shown that preferences in this scenario are highly dependent on affected women’s personalities and value systems. To support these women in the decision-making process, a structured decision support consisting of decision coaching combined with a decision aid might be helpful. Methods/design: A randomized controlled trial will be conducted in order to compare usual care with structured decision support alongside usual care. The decision support program entails nurse-led decision coaching as well as an evidence-based patient decision aid. Nurses are qualified by a 4-day training program in informed decision-making and decision coaching. Six centers for Familial Breast and Ovarian Cancer in Germany will be included in the study, with a planned sample size of 398 women. The primary outcome is the congruence between the preferred and the actual played role in the decision-making process as measured by the Control Preferences Scale. It is hypothesized that the structured decision support will enable women to play the preferred role in the decision-making process. Secondary outcomes include the knowledge and attitudes about preventive options, decisional conflict, depression and anxiety, coping self-efficacy, impact of event, and self-concept. A process evaluation will accompany the study. Discussion: The EDCP-BRCA study is the first study to implement and evaluate decision coaching combined with a decision aid for healthy BRCA mutation carriers worldwide. Trial registration {2a}: DRKS-ID: DRKS00015527. Registered 30 October 2019.

Zusammenfassung: Das vorliegende „DNVF Memorandum Gesundheitskompetenz (Teil 2) – Operationalisierung und Messung von Gesundheitskompetenz aus Sicht der Versorgungsforschung“ des Deutschen Netzwerks Versorgungsforschung e.V. (DNVF) stellt die Fortführung des Memorandums „DNVF Memorandum Gesundheitskompetenz (Teil 1) – Hintergrund, Gegenstand und Fragestellungen in der Versorgungsforschung“ dar. Neben den allgemeinen Anforderungen an die Messung der Gesundheitskompetenz, beschäftigt sich dieses Memorandum auch mit den speziellen Anforderungen, wie die Abgrenzung zu verwandten Konstrukten, den Unterschieden zwischen performanzbasierten und Selbsteinschätzungsverfahren, den Unterschieden zwischen generischen und spezifischen Instrumenten, dem Einsatz von Screeninginstrumenten sowie der Messung der Gesundheitskompetenz bei speziellen Personengruppen. Weiterhin werden Besonderheiten bei der Messung der digitalen Gesundheitskompetenz, Potenziale qualitativer und partizipativer Forschungszugänge sowie forschungsethische Gesichtspunkte bei der Messung der Gesundheitskompetenz erarbeitet. Ein besonderer Wert wird auf den Praxisbezug gelegt, der am Ende der jeweiligen Abschnitte mit einem Fazit für die Versorgungsforschung aufgegriffen wird. Abschließend wird einen Blick auf Herausforderungen und Forschungsdesiderate im Zusammenhang mit der Messung von Gesundheitskompetenz im Rahmen der Versorgungsforschung geworfen.

After acute care of a cardiac event, cardiac rehabilitation helps future disease management. Patients with low health literacy have been shown to have fewer knowledge gains from rehabilitation and higher all-cause mortality after acute cardiac events. Cardiac rehabilitation may be the best channel to target population with low health literacy, yet research on this topic is limited. Consequently, the main aim of the current study was to identify patient perceptions about the health literacy domains that are needed for successful rehabilitation of patients attending German cardiac rehabilitation clinics after an acute cardiac event. Five focus group interviews with 25 inpatients (80% male, 20% female) were conducted at a cardiac rehabilitation clinic in Germany. Patients were eligible to participate if they had sufficient understanding of the German language and had no other debilitating diseases. Patients identified five domains of health literacy for rehabilitation success: knowledge about their health condition; being able to find and evaluate health-related information, being able to make plans and sticking to them, assumption of responsibility over one’s health and the ability to ask for and receive support. The results give an important insight into what patients perceive as important components of their cardiac rehabilitation, which can provide the basis for developing the health literacy of patients and how cardiac rehabilitation clinics respond to the recovery needs of their patients.

Female BRCA1/2 pathogenic variant carriers have an increased lifetime risk for breast and ovarian cancer. Cancer-unaffected women who are newly diagnosed with this pathogenic variant may experience psychological distress because of imminent health threat. No comprehensible review on psychological morbidity in cancer-unaffected BRCA1/2 pathogenic variant carriers is currently available. This review aims to give an overview about all available the studies in which psychological outcomes have been assessed in cancer-unaffected BRCA1/2 pathogenic variant carriers, whether as a primary outcome or secondary measurement. A systematic search across four databases (Web of Science, PubMed, ScienceDirect, and EBSCO) was conducted. Studies had to report on cancer-unaffected pathogenic variant carriers (exclusively or separately) and use a validated measure of psychological morbidity to be eligible. Measures were only included if they were used in at least three studies. The final review consisted of 45 studies from 13 countries. Distress measures, including anxiety and cancer worry, were most often assessed. Most studies found a peak of distress immediately after genetic test result disclosure, with a subsequent decline over the following months. Only some studies found elevated distress in carriers compared to non-carriers in longer follow-ups. Depression was frequently investigated but largely not found to be of clinical significance. Quality of life seemed to be largely unaffected by a positive genetic test result, although there was some evidence that younger women, especially, were less satisfied with their role functioning in life. Body image has been infrequently assessed so far, but the evidence suggested that there may be a decrease in body image after genetic test result disclosure that may decrease further for women who opt for a prophylactic mastectomy. Across all the outcomes, various versions of instruments were used, often limiting the comparability among the studies. Hence, future research should consider using frequently used instruments, as outlined by this review. Finally, while many studies included cancer-unaffected carriers, they were often not reported on separately, which made it difficult to draw specific conclusions about this population.

Women who are found to carry a BRCA1/2 pathogenic variant experience psychological distress due to an increased risk of breast and ovarian cancer. They may decide between different preventive options. In this secondary analysis of data collected alongside a larger randomized controlled trial, we are looking at 130 newly found BRCA1/2 pathogenic variant carriers and how their coping self-efficacy immediately after genetic test result disclosure is related to their psychological burden and status of preventive decision making. Participants received the Coping Self-Efficacy Scale, the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the Decisional Conflict Scale, and the Stage of Decision-Making Scale after positive genetic test result disclosure. We found that women with higher coping self-efficacy showed fewer symptoms of anxiety or depression and were less affected by receiving the genetic test result in terms of post-traumatic stress. However, coping self-efficacy had no relationship with any decision-related criteria, such as decisional conflict or stage of decision making. This shows that despite its buffering capacity on psychological burden, possessing coping self-efficacy does not lead to more decisiveness in preference-sensitive decisions.