Isselhard, A., Toepper, M., Berger-Hoeger, B., Steckelberg, A., Fischer, H., Vitinius, F., Beifus, K., Koeberlein-Neu, J., Wiedemann, R., Rhiem, K., Schmutzler, R. and Stock, S. (2020). Implementation and evaluation of a nurse-led decision-coaching program for healthy breast cancer susceptibility gene (BRCA1/2) mutation carriers: a study protocol for the randomized controlled EDCP-BRCA study. Trials, 21 (1). LONDON: BMC. ISSN 1745-6215

Full text not available from this repository.

Abstract

BackgroundFemale 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/designA 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.DiscussionThe 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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Isselhard, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Toepper, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berger-Hoeger, B.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Steckelberg, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fischer, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vitinius, F.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beifus, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koeberlein-Neu, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wiedemann, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rhiem, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmutzler, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stock, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-330345
DOI: 10.1186/s13063-020-04431-x
Journal or Publication Title: Trials
Volume: 21
Number: 1
Date: 2020
Publisher: BMC
Place of Publication: LONDON
ISSN: 1745-6215
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
PROPHYLACTIC MASTECTOMY; HEREDITARY BREAST; CONTROLLED-TRIAL; EVENT SCALE; WOMEN; RISK; OVARIAN; IMPACT; INTENTION; OOPHORECTOMYMultiple languages
Medicine, Research & ExperimentalMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/33034

Downloads

Downloads per month over past year

Altmetric

Export

Actions (login required)

View Item View Item