A Model Informed Consent Process for BRCA1 Testing

This study will develop, implement and evaluate a model informed consent (IC) process for genetic testing for breast cancer that integrates the perceptions of consumers and providers. The model IC process will address both content and style of disclosure and counseling. The study will develop and utilize surveys of providers and consumers to determine the knowledge, expectations and perceptions of both groups of genetic testing for breast cancer. After examining discrepancies between and among groups of consumers and providers, model educational materials will be developed for the IC process that reflect the expectations of consumers and providers. A pilot BRCA1 testing program will be implemented that incorporates the content of disclosure appropriate for each category of patient, and randomizes 140 female and male patients who are eligible and interested in BRCA1 testing to one of two disclosure styles: individual or group pre-test education and counseling. We will evaluate both the content and style of our model IC process in terms of patient knowledge, satisfaction, perceived decision-making autonomy and testing decisions. Our findings will have implications for the offering and utilization of genetic testing for breast and ovarian cancer, and for the development of IC guidelines, and will point to necessary improvements in medical training with regard to consent for predictive testing. (Funded by the NINR. Member of CGSC)