Though there has been considerable recent research on genetic testing for breast-ovarian cancer susceptibility, most of it has focused on breast cancer survivors and their unaffected relatives. However, BRCA1/2 mutation status is also relevant for treatment decision-making in newly diagnosed breast cancer patients. Breast cancer patients who carry a BRCA1/2 mutation have up to a 65% risk of developing contralateral breast cancer. As a result, bilateral mastectomy has emerged as a viable treatment option for these patients. Although guidelines suggest that breast cancer patients with a family history suggestive of hereditary breast cancer should be referred for genetic evaluation, they do not indicate when patients should be referred with respect to their definitive treatment. As a result there is disagreement regarding the optimal timing of genetic risk assessment. There are potential advantages and disadvantages to pre-surgical referral. To date, however, there have been no controlled trials to evaluate the outcomes of pre-surgical genetic counseling. In our previous study, we evaluated the feasibility and impact of pre-surgical BRCA1/2 counseling and testing in a research sample of self-selected patients. This study demonstrated an impact of genetic counseling on surgery decisions and quality of life. However, these results are limited by participant selection factors and the lack of random assignment. Thus, we propose a novel randomized trial to evaluate the impact of pre-surgical genetic counseling (versus usual care) for newly diagnosed breast cancer patients. Guided by the Ottawa Decision Support Framework, the specific aims, of the proposed trial are: 1) To evaluate the impact of Rapid Genetic Counseling (RGC) vs. Usual Care (UC) oh medical decisions', 2) To evaluate the impact of RGC vs. UC on quality of life and psychosocial well-being; 3) To identify baseline factors that predict who is most and least likely to benefit from RGC; and 4) to evaluate the cost effectiveness of the RGC intervention.
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