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    Research Grants Awarded

    Individualized Risk Information System (IRIS) for BRCA Carriers

    Study Section:
    RISK and Prevention, Epidemiology

    Scientific Abstract:
    Background: Breast cancer (BC) patients with a BRCA gene mutation ( BRCA +) are at high risk for a second BC and for ovarian cancer. Helping these women decide amongst several risk-reducing options requires effectively conveying complex emotionally laden cancer risk and risk management information. To provide individualized numerical BC risk and survival information for various risk management options (e.g., mastectomy, oophorectomy, both, or neither), we developed an innovative prototype computerized counseling tool, Individualized Risk Information System (IRIS), based on prospective outcomes data of 491 BRCA + patients. Validating IRIS’s predictive model and integrating a decision support system assessing personal values and preferences into IRIS, would yield a tool to improve women’s decision-making and satisfaction. Objective/Hypothesis: To validate IRIS, and improve women’s decision-making about risk-reducing options, by developing a unique innovative interactive tool (IRIS) that combines individualized risk information with decision support. H1: IRIS’s predictions will be highly concordant with true outcomes, within strata and across the entire validation patient population. H2: IRIS will effectively convey cancer risk/risk management information and enhance women’s decision-making. Aims: 1) Validate the IRIS predictive models using independent BRCA + BC patient clinical outcome datasets, 2) design and integrate into IRIS a decision support system incorporating women’s values and preferences, and 3) revise IRIS using focus group feedback. Design: We will use: 2 datasets to validate IRIS’s predictions, the Ottowa decision aid framework to design and integrate a decision support tool into IRIS to enhance risk counseling and risk reduction decision-making for BRCA + women with BC, and feedback from 8 focus groups of BC clinicians, patients, and advocates to revise IRIS. Potential Outcomes: A validated computerized interactive decision support tool that incorporates individualized risk assessment with an assessment and valuation of potential courses of action will: 1) help women make informed decisions congruent with personal values/preferences, resulting in higher satisfaction with their decisions and the decision-making process, and 2) provide critical pilot data for prospective studies of IRIS’s effect on this high-risk population, prior to testing in a randomized controlled trial.

    Lay Abstract:
    Women who inherit a mutation (mistake) in the BRCA1 or BRCA2 genes have a very high risk for breast and ovarian cancers. Women with BRCA -associated breast cancer (BC) may consider medical and surgical options to reduce the risk of a new breast cancer. Key to helping women make informed decisions about these options is presenting complex cancer risk/risk management information clearly and understandably. To provide risk information and strengthen women’s role in the decision-making process, we developed an innovative interactive computerized counseling tool, Individualized Risk Information System (IRIS), based on a large study of outcomes for BRCA + patients. IRIS provides individualized numerical information about a woman’s second BC risk given various risk management options (e.g., removal of breasts, ovaries, both, or neither). Validating IRIS’s predictions and designing/integrating a decision support system assessing women’s personal values and preferences into IRIS, is critical to enabling decision-making that reflects women’s personal values and preferences, resulting in higher satisfaction with decisions and the decision-making process. We will: (1) Validate IRIS’s numerical predictions by comparing it to outcomes of two large studies of BRCA + BC patients, to ensure that IRIS’s output is accurate, (2) Design and incorporate into IRIS a decision aid that asks about patient values and preferences regarding risk reduction options, and (3) Pilot-test the new version of IRIS for functionality, understandability, and emotive effect using 8 focus groups (2 groups each of genetic counselors /medical geneticists; medical and surgical oncologists; previously counseled BRCA + patients with a prior BC; and BC advocates). IRIS is unique in that it is the first interactive computerized program providing BRCA + BC patients with individualized predictions about second cancer risks and takes into account values and preferences. BC patients and advocates will participate in focus groups to contribute their thoughts, feelings and suggestions about IRIS’s appearance, features, and emotional effects, and recommendations for improvement. Future research will test IRIS in the clinical setting. Ultimately, IRIS will fill a crucial need of helping women make decisions about potentially life-altering risk-reducing options.