During this fiscal year this education and counseling protocol has been conceived, written, and approved by the NCI IRB. The objectives of the study are; (1) to identify family characteristics and personality traits and beliefs that significantly effect individual decisions regarding BRCA1 testing such as, religious and spiritual beliefs and previous direct experience with cancer; (2) to characterize the impact of negative vs. positive BRCA1 test results on family relationships and psychological status; (3) to predict responses to specific counseling regarding risk status based on individual personality profiles to predict who is at greatest risk for experiencing negative effects on close relationships; (4) to assess expectations regarding testing and how these influence perceptions of risks and responses to risk notification; (5) to evaluate the impact of risk notification on the frequency of surveillance and prevention activities; and (6) to compare a client-driven pre-test session to a counselor-driven, problem-solving approach. Much of the year has been spent choosing or adapting the testing instruments, developing the prioritization criteria and amending the consents via a bi-weekly research meeting. The team has added a bio-ethics consultant, Dr. Evan DeRenzo, and a very new team member, June Peters, M.S., genetic counselor. Families have been prioritized according to international data on BRCA1 mutations (how often the mutation has been reported in cancer prone families) and the characteristic of the mutation (frameshifts being more likely to confer disease risk). This project has enrolled 22 individuals from three distinct extended families to date. Individualized psychometrics, education and counseling have been provided. The majority of participants have chosen to undergo BRCA1 testing. As of September 1, 1995, no subjects had been given their test results. This protocol has been integrated into the ELSI Extramural Hereditary Cancer Consortium. This entailed agreeing to core psychometric assessment, consent items and surveillance recommendations. The intent is to share resources and to pool research data to the degree possible from this collaborative effort.
