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01-12-2022 | Breast Cancer | Study protocol

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

Authors: Sibylle Kautz-Freimuth, Marcus Redaèlli, Anna Isselhard, Arim Shukri, Andrea Vodermaier, Kerstin Rhiem, Rita Schmutzler, Stephanie Stock

Published in: Trials | Issue 1/2022

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

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Title: Evaluation of two evidence-based decision aids for female BRCA1/2 mutation carriers in Germany: study protocol for a randomised controlled parallel-group trial
Authors: Sibylle Kautz-Freimuth
Marcus Redaèlli
Anna Isselhard
Arim Shukri
Andrea Vodermaier
Kerstin Rhiem
Rita Schmutzler
Stephanie Stock
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Breast Cancer
Ovarian Cancer
Ovarian Cancer
Care
Breast Cancer
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-06081-7

At a glance: The STEP trials

Springer Medicine

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

Methods

Discussion

Trial registration {2a}

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration {2a}

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