Evaluating Informed Consent in BRCA1/2 Screening

This study will develop and validate (1) alternative methods for administering informed consent (IC) procedures to a diverse population of women at increased risk for breast cancer, and 2) standardized instruments to evaluate the effect of alternative methods on both comprehension and willingness to participate in research that includes screening for BRCA1/2 mutations. The study focuses on the 'informed' part of informed consent and reflects the principles and methods of cognitive-based theories of decision making and risk communication. The study will be conducted in three stages. In stage 1, counseling protocols and IC forms used in pervious research that involved BRCA1/2 screening will be compiled and evaluated. During stage two a control condition that reflects 'best current IC practices' will be developed along with two experimental conditions based on the deliberations of expert and lay panels. Also during stage 2, a standardized instrument to evaluate change in subjects' knowledge and beliefs about breast cancer and BRCA1/2 screening will be developed. In Stage 3 a standardized instrument will be administered to 456 first-degree relatives of women recently diagnosed with breast cancer before they are randomly assigned to and after they receive one of the IC conditions. Both process and outcome evaluation data will be collected. Outcomes will include changes in knowledge, attitudes and beliefs about breast cancer and genetic screening as well as willingness to participate in a research study that would include BRCA1/2 testing. (Informed Consent RFA. Co-funded)