Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Feb 16;23(1):157.
doi: 10.1186/s13063-022-06081-7.

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

Sibylle Kautz-Freimuth  1 , Marcus Redaèlli  2 , Anna Isselhard  2 , Arim Shukri  2 , Andrea Vodermaier  2   3 , Kerstin Rhiem  4 , Rita Schmutzler  4 , Stephanie Stock  2
Affiliations

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

Sibylle Kautz-Freimuth et al. Trials. .

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.

Keywords: BRCA1 mutation; BRCA2 mutation; Decision aid; Decision-making; Evaluation study; Familial breast and ovarian cancer; Hereditary breast and ovarian cancer (HBOC); Patient-centred care; Preference-sensitive decisions; Preventive measures.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Participant timeline
See this image and copyright information in PMC

References

    1. Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ, Jervis S, van Leeuwen FE, Milne RL, Andrieu N, Goldgar DE, Terry MB, Rookus MA, Easton DF, Antoniou AC, and the BRCA1 and BRCA2 Cohort Consortium. McGuffog L, Evans DG, Barrowdale D, Frost D, Adlard J, Ong KR, Izatt L, Tischkowitz M, Eeles R, Davidson R, Hodgson S, Ellis S, Nogues C, Lasset C, Stoppa-Lyonnet D, Fricker JP, Faivre L, Berthet P, Hooning MJ, van der Kolk LE, Kets CM, Adank MA, John EM, Chung WK, Andrulis IL, Southey M, Daly MB, Buys SS, Osorio A, Engel C, Kast K, Schmutzler RK, Caldes T, Jakubowska A, Simard J, Friedlander ML, McLachlan SA, Machackova E, Foretova L, Tan YY, Singer CF, Olah E, Gerdes AM, Arver B, Olsson H. Risks of breast, ovarian, and contralateral breast cancer for BRCA1 and BRCA2 mutation carriers. JAMA. 2017;317(23):2402–2416. doi: 10.1001/jama.2017.7112. - DOI - PubMed
    1. Engel C, Fischer C, Zachariae S, Buksch K, Rhiem K, Giesecke J, et al. on the behalf of the German Consortium for Hereditary Breast and Ovarian Cancer. Breast cancer risk in BRCA1/2 mutation carriers and noncarriers under prospective intensified surveillance. Int J Cancer. 2019;146(4):999–1009. doi: 10.1002/ijc.32396. - DOI - PubMed
    1. Dean M, Scherr CL, Clements M, Koruo R, Martinez J, Ross A. “When information is not enough”: a model for understanding BRCA-positive previvors’ information needs regarding hereditary breast and ovarian cancer risk. Patient Educ Couns. 2017;100(9):1738–1743. doi: 10.1016/j.pec.2017.03.013. - DOI - PubMed
    1. World Cancer Research Fund/American Institute for Cancer Research. Continuous update project expert report . Diet, nutrition, physical activity and breast cancer survivors. 2018.
    1. Rhiem K, Engel C, Graeser M, Zachariae S, Kast K, Kiechle M, et al. The risk of contralateral breast cancer in patients from BRCA1/2 negative high risk families as compared to patients from BRCA1 or BRCA2 positive families: a retrospective cohort study. Breast Cancer Res. 2012;14(6):R156. doi: 10.1186/bcr3369. - DOI - PMC - PubMed

Publication types