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Randomized Controlled Trial
Randomized trial of a decision aid for BRCA1/BRCA2 mutation carriers: impact on measures of decision making and satisfaction.
- Marc D Schwartz, Heiddis B Valdimarsdottir, Tiffani A DeMarco, Beth N Peshkin, William Lawrence, Jessica Rispoli, Karen Brown, Claudine Isaacs, Suzanne O'Neill, Rebecca Shelby, Sherry C Grumet, Margaret M McGovern, Sarah Garnett, Heather Bremer, Suzanne Leaman, Kathryn O'Mara, Sarah Kelleher, and Kathryn Komaridis.
- Department of Oncology, Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC 20007, USA. schwartm@georgetown.edu
- Health Psychol. 2009 Jan 1;28(1):11-9.
ObjectiveGenetic testing is increasingly part of routine clinical care for women with a family history of breast cancer. Given their substantially elevated risk for breast cancer, BRCA1/BRCA2 mutation carriers must make the difficult decision whether or not to opt for risk reducing mastectomy. To help BRCA1/2 carriers make this decision, the authors developed a computer-based interactive decision aid that was tested against usual care in a randomized controlled trial.DesignAfter the completion of genetic counseling, 214 female (aged 21-75) BRCA1/BRCA2 mutation carriers were randomized to Usual Care (UC; N = 114) or Usual Care plus Decision Aid (DA; N = 100) arms. UC participants received no additional intervention. DA participants were sent the CD-ROM DA to view at home.Main Outcome MeasuresThe authors measured final management decision, decisional conflict, decisional satisfaction, and receipt of risk reducing mastectomy at 1-, 6-, and 12-months postrandomization.ResultsLongitudinal analyses revealed that the DA was effective among carriers who were initially undecided about how to manage their breast cancer risk. Within this group, the DA led to an increased likelihood of reaching a management decision (OR = 3.09, 95% CI = 1.62, 5.90; p < .001), decreased decisional conflict (B = -.46, z = -3.1, p <002), and increased satisfaction (B = .27, z = 3.1, p = .002) compared to UC. Among carriers who had already made a management decision by the time of randomization, the DA had no benefit relative to UC.ConclusionThese results demonstrate that BRCA1/BRCA2 mutation carriers who are having difficulty making a breast cancer risk management decision can benefit from adjunct decision support.(c) 2009 APA, all rights reserved.
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