CONTROLLED TRIAL OF PRETEST EDUCATION APPROACHES TO ENHANCE INFORMED DECISION-MAKING FOR BRCA1 GENE TESTING

Background: In response to the isolation of the BRCA1 gene, a breast-o varian cancer-susceptibility gene, biotechnology companies are already marketing genetic tests to health care providers and to the public. I nitial studies indicate interest in BRCA1 testing in the general publi c and in populations at high risk. However, the optimal strategies for educating and counseling individuals have Set to be determined. Purpo se: Our goal was to evaluate the impact of alternate strategies for pr etest education and counseling on decision-making regarding BRCA1 test ing among women at low to moderate risk who have a family history of b reast and/or ovarian cancer. Methods: A randomized trial design was us ed to evaluate the effects of education only (educational approach) an d education plus counseling (counseling approach), as compared with a waiting-list (control) condition in = 400 for all groups combined). Th e educational approach reviewed information about personal risk factor s, inheritance of cancer susceptibility, the benefits, limitations, an d risks of BRCA1 testing, and cancer screening and prevention options. The counseling approach included this information, as well as a perso nalized discussion of experiences with canter in the family and the po tential psychological and social impact of testing. Data on knowledge of inherited cancer and BRCA1 test characteristics, perceived risk, pe rceived benefits, limitations and risks of BRCA1 testing, and testing intentions were collected by use of structured telephone interviews at baseline and at 1-month follow-up. Provision of a blood sample for fu ture testing served Its a proxy measure of intention to be tested (in the education and counseling arms of the study). The effects of interv ention group on study outcomes were evaluated by use of hierarchical l inear regression modeling and logistic regression modeling (for the bl ood sample outcome). All P values are for two-sided tests. Results: Th e educational and counseling approaches both led to significant increa ses in knowledge, relative to the control condition (P<.001 for both). The counseling approach, but not the educational approach, was superi or to the control condition in producing significant increases in perc eived limitations and risks of BRCA1 testing (P<.01) and decreases in perceived benefits (P<.05). However, neither approach produced changes in intentions to have BRCA1 testing. Prior to and following both educ ation only and education plus counseling, approximately one half of th e participants stated that they intended to be tested; after the sessi on, 52% provided a blood sample. Conclusions: Standard educational app roaches may be equally effective as expanded counseling approaches in enhancing knowledge. Since knowledge is a key aspect of medical decisi on-making, standard education mag be adequate in situations where gene tic testing must be streamlined. On the other hand, it has been argued that optimal decision-making requires not only knowledge, but also a reasoned evaluation of the positive and negative consequences of alter nate decisions. Although the counseling approach is more likely to ach ieve this goal, it may not diminish interest in testing, even among wo men at low to moderate risk. Future research should focus on the merit s of these alternate approaches for subgroups of individuals with diff erent backgrounds who are being counseled in the variety of settings w here BRCA1 testing is likely to be offered.