FACILITATING INFORMED DECISIONS ABOUT BRCA1 TESTING

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The identification of breast cancer susceptibility genes is a recent phenomena. In fact, since the initial submission of this application a second breast cancer susceptibility gene, BRCA2, was identified. Many questions must be answered, as genetic testing becomes standard clinical practice. What information do women need to make an informed decision about testing? What is the psychological and psychosocial impact of BRCA1/BRCA2 testing on breast and ovarian cancer patients and their relatives? Since work on this project began, we have assembled valuable information concerning the attitudes, beliefs and information needs about BRCA1 and BRCA2 testing. An intervention trial, using Tailored Informed Consent Information and Usual Care Informed Consent developed in year one is well underway. All subjects will have been determined to be at high risk of BRCA1/BRCA2 positive based on family history, and they will be offered genetic testing. It is hypothesized that the Tailored Informed Consent group will have fewer intrusive thoughts about breast cancer, improved knowledge about genetic testing, and more accurate perception of their breast cancer risk (relatives only). Tailored materials are prepared for an individual based on information known about that person and have the potential to extend the research of health professional by providing information needed to make decisions and the pre-test phase of the counseling process. Due to the vast infrastructure needs for this and related projects, including consent materials, questionnaire instruments, a database, and a genetic testing facility, accrual began later than initially planned. However, as we entered year three, the intervention trial has enrolled 182 family members and is operating with a state-of- the-art infrastructure and staff as well as referral base from within and outside our institution, including the Dana-Farber Cancer Institute, Presbyterial Hospital in Charlotte, NC and Florida Hospital. We anticipate the completion of the enrollment of 400 study participants in the first year of year four. Counseling, genetic testing and follow-up will continue through the first half of year five. Statistical analyses to answer the main study hypotheses will be in progress in year four and completed by the end of year five, thus accomplishing all the original aims of this study. We believe that this research will lead to improved decision-making concerning BRCA1/BRCA2 testing and a better understanding of the psychosocial impact of genetic testing for breast cancer.