Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing

OBJECTIVES:

• Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian cancer families.
• Evaluate the long-term impact of genetic counseling and testing on psychosocial and behavioral outcomes.
• Evaluate the relative impact of standard genetic counseling (SGC) versus SGC plus the interactive decision-aid (IDA) on medical decision-making.
• Evaluate the relative impact of SGC vs SGC + IDA on psychological well-being.
• Explore the mechanisms by which the SGC + IDA intervention impacts on psychosocial and behavioral outcomes.

OUTLINE: This is a multicenter study.

Eligible women are asked to participate in a baseline telephone interview over 30 minutes and then invited to a genetic counseling session over 1.5-2 hours that includes information about BRCA1/2 testing. Patients are then offered BRCA1/2 testing, and the test results (i.e., mutation carrier vs noncarrier) are presented at a subsequent in-person individual genetic counseling session over 1.5-2 hours. Patients who tested positive for BRCA1 or 2 mutation are randomized to 1 of 2 counseling arms. All other patients proceed to follow up.

• Arm I (standard genetic counseling): No further counselor-initiated contact is scheduled.
• Arm II (individualized decision aid): Patients are asked to view an interactive computer program that is designed to help the patients make medical decisions based on their breast cancer risk.