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
Randomized Controlled Trial
. 2008 Oct 3:8:283.
doi: 10.1186/1471-2407-8-283.

Design of the BRISC study: a multicentre controlled clinical trial to optimize the communication of breast cancer risks in genetic counselling

Caroline F Ockhuysen-Vermey  1 , Lidewij Henneman, Christi J van Asperen, Jan C Oosterwijk, Fred H Menko, Daniëlle R M Timmermans
Affiliations
Randomized Controlled Trial

Design of the BRISC study: a multicentre controlled clinical trial to optimize the communication of breast cancer risks in genetic counselling

Caroline F Ockhuysen-Vermey et al. BMC Cancer. .

Abstract

Background: Understanding risks is considered to be crucial for informed decision-making. Inaccurate risk perception is a common finding in women with a family history of breast cancer attending genetic counseling. As yet, it is unclear how risks should best be communicated in clinical practice. This study protocol describes the design and methods of the BRISC (Breast cancer RISk Communication) study evaluating the effect of different formats of risk communication on the counsellee's risk perception, psychological well-being and decision-making regarding preventive options for breast cancer.

Methods and design: The BRISC study is designed as a pre-post-test controlled group intervention trial with repeated measurements using questionnaires. The intervention-an additional risk consultation-consists of one of 5 conditions that differ in the way counsellee's breast cancer risk is communicated: 1) lifetime risk in numerical format (natural frequencies, i.e. X out of 100), 2) lifetime risk in both numerical format and graphical format (population figures), 3) lifetime risk and age-related risk in numerical format, 4) lifetime risk and age-related risk in both numerical format and graphical format, and 5) lifetime risk in percentages. Condition 6 is the control condition in which no intervention is given (usual care). Participants are unaffected women with a family history of breast cancer attending one of three participating clinical genetic centres in the Netherlands.

Discussion: The BRISC study allows for an evaluation of the effects of different formats of communicating breast cancer risks to counsellees. The results can be used to optimize risk communication in order to improve informed decision-making among women with a family history of breast cancer. They may also be useful for risk communication in other health-related services.

Trial registration: Current Controlled Trials ISRCTN14566836.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Time planning of the intervention and questionnaires in the intervention group (conditions 1–5) and control group (condition 6).
Figure 2
Figure 2
Risk communication formats in conditions 1–4.
Figure 3
Figure 3
Example of graphical risk format used in condition 4. "In the current situation, on average 2 out of 100 women in the Netherlands of the same age as you (40), will develop breast cancer in the next ten years"
See this image and copyright information in PMC

References

    1. Julian-Reynier C, Welkenhuysen M, Hagoel L, Decruyenaere M, Hopwood P. Risk communication strategies: state of the art and effectiveness in the context of cancer genetic services. Eur J Hum Genet. 2003;11:725–736. doi: 10.1038/sj.ejhg.5201037. - DOI - PubMed
    1. Easton DF, Bishop DT, Ford D, Crockford GP. Genetic linkage analysis in familial breast and ovarian cancer: results from 214 families. The Breast Cancer Linkage Consortium. Am J Hum Genet. 1993;52:678–701. - PMC - PubMed
    1. Visser O, Siesling S, van Dijck JAAM. Incidence of cancer in the Netherlands 1999/2000 Eleventh report of The Netherlands Cancer Registry. Utrecht: Association of Comprehensive Cancer Centres; 2003.
    1. Ford D, Easton DF, Stratton M, Narod S, Goldgar D, Devilee P, Bishop DT, Weber B, Lenoir G, Chang-Claude J, Sobol H, Teare MD, Struewing J, Arason A, Scherneck S, Peto J, Rebbeck TR, Tonin P, Neuhausen S, Barkardottir R, Eyfjord J, Lynch H, Ponder BA, Gayther SA, Zelada-Hedman M. Genetic heterogeneity and penetrance analysis of the BRCA1 and BRCA2 genes in breast cancer families. The Breast Cancer Linkage Consortium. Am J Hum Genet. 1998;62:676–689. doi: 10.1086/301749. - DOI - PMC - PubMed
    1. Struewing JP, Hartge P, Wacholder S, Baker SM, Berlin M, McAdams M, Timmerman MM, Brody LC, Tucker MA. The risk of cancer associated with specific mutations of BRCA1 and BRCA2 among Ashkenazi Jews. N Engl J Med. 1997;336:1401–1408. doi: 10.1056/NEJM199705153362001. - DOI - PubMed

Publication types

Associated data