Universität zu Köln

Kautz-Freimuth, Sibylle, Redaelli, Marcus ORCID: 0000-0001-8830-1999, Isselhard, Anna, Shukri, Arim, Vodermaier, Andrea, Rhiem, Kerstin, Schmutzler, Rita and Stock, Stephanie (2022). Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial. Trials, 23 (1). LONDON: BMC. ISSN 1745-6215

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Kautz-Freimuth, Sibylle UNSPECIFIED UNSPECIFIED UNSPECIFIED Redaelli, Marcus UNSPECIFIED orcid.org/0000-0001-8830-1999 UNSPECIFIED Isselhard, Anna UNSPECIFIED UNSPECIFIED UNSPECIFIED Shukri, Arim UNSPECIFIED UNSPECIFIED UNSPECIFIED Vodermaier, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Rhiem, Kerstin UNSPECIFIED UNSPECIFIED UNSPECIFIED Schmutzler, Rita UNSPECIFIED UNSPECIFIED UNSPECIFIED Stock, Stephanie UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-669621
DOI:	10.1186/s13063-022-06081-7
Journal or Publication Title:	Trials
Volume:	23
Number:	1
Date:	2022
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1745-6215
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language REDUCING SALPINGO-OOPHORECTOMY; BREAST-CANCER PREVENTION; OVARIAN-CANCER; WOMEN; RISK; IMPACT; CONFLICT; SURGERY; METAANALYSIS; FRAMEWORK Multiple languages Medicine, Research & Experimental Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/66962