The investigators propose a prospective, longitudinal study to examine decision-making about pre-surgery BRCA1/2 testing and the medical, psychosocial, and economic outcomes of testing among newly-diagnosed breast cancer patients who are at high risk for having a BRCA1/2 mutation. The theoretical framework for this investigation is derived from Expected Utility Theory.
The Specific aims are (1) to establish rates of uptake of the BRCA1/2 testing prior to surgical treatment for breast cancer and to identify the determinants of the decision to be tested; (2) to evaluate the impact of BRCA1/2 testing on patients' surgical treatment choices; (3) to evaluate the impact of pre-surgery BRTCA1/2 testing on psychological well-being; and (4) to develop a model to estimate the costs of BRCA1/2 testing for newly-diagnosed breast cancer patients per quality-adjusted life years saved. The subjects in this prospective longitudinal study are 400 newly diagnosed breast cancer patients who have an equal to or greater than 25 percent prior probability of having a BRCA1/2 mutation. A baseline assessment will be conducted prior to the offer of testing to collect data on background/controlling variables (sociodemographics, medical, physician and family factors), predictor/moderator variables (preferences for health outcomes, coping style, anxiety, social support), and baseline levels of outcome variables (psychosocial well being, prevention and surveillance practices). Following pre-test education and informed consent, patients will have an opportunity to have BRCA1/2 testing and receive their result during an individual session with a genetic counselor. Follow-up interviews will be conducted at 1-, 6-, 12-, and 18-months post-surgery to collect outcome data. The primary group comparisons in multiple regression models will be between BRCA1/2 carriers, non carriers, and pre-surgery test decliners. The proposed cost-effectiveness analysis will incorporate prospective data on patient preferences and outcomes together with secondary data from the literature, into a decision-analytic model.
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