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Randomized Trial of a Shared Decision-Making Intervention Consisting of Trade-Offs and Individualized Treatment Information for BRCA1/2 Mutation Carriers

From the Department of Radiotherapy, Department of Human Genetics and Hereditary Cancer Clinic, University Medical Center Nijmegen; Medical Technology Assessment, University of Nijmegen, Nijmegen; Department of Medical Psychology, Department of Clinical Genetics, University Hospital Groningen, Groningen; and Department of Clinical Genetics, University Hospital Maastricht, Maastricht, the Netherlands

Address reprint requests to Mariëlle van Roosmalen, MD, Department of Radiotherapy (341), University Medical Center Nijmegen, PO Box 9101, 6500 HB Nijmegen, the Netherlands; e-mail: m.vanroosmalen{at}rther.umcn.nl

PURPOSE: To evaluate a shared decision-making intervention (SDMI) for BRCA1/2 mutation carriers who have to make a choice between screening and prophylactic surgery for breasts and/or ovaries.

PATIENTS AND METHODS: The SDMI consisted of two value assessment sessions, using the time trade-off method, followed by individualized treatment information based on (quality-adjusted) life expectancy. After the baseline assessment (2 weeks after a positive DNA test result), women were randomly assigned to the SDMI group (n = 44), receiving the SDMI 2 months after the test result, or to the control group (n = 44). The short- and long-term effects, 3 and 9 months after the test result, were assessed using questionnaires. Data were collected on well-being, treatment choice, and decision-related outcomes.

RESULTS: In the short term, the SDMI had no effect. In the long term, with respect to well-being, patients in the SDMI group had less intrusive thoughts (P = .05) and better general health (P = .01) and tended to be less depressed (P = .07). With respect to decision-related outcomes for the breasts, the SDMI group held stronger preferences (P = .02) and agreed more strongly to having weighed the pros and cons (P = .01). No effect was found on treatment choice. In the long term, interaction effects between the SDMI and cancer history were found. The SDMI showed an overall beneficial effect for unaffected women, whereas affected women tended to experience detrimental effects.

CONCLUSION: We conclude that the SDMI improved decision making in unaffected BRCA1/2 mutation carriers. Supporting decision making in a systematic way using trade-offs is beneficial for these women.

Supported by a grant from the Dutch Cancer Society (grant No. 98-1585), Amsterdam, the Netherlands.

Preliminary results of this study were presented at the 24th Annual Meeting of the Society for Medical Decision Making, Baltimore, MD, October 19-23, 2002.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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