Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing
- Evaluate the impact of BRCA1/BRCA2 testing among members of hereditary breast-ovarian
- Evaluate the long-term impact of genetic counseling and testing on psychosocial and
- 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
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
- 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.
Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12
PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
subjects will complete questionnaires re; genetic counseling experience
Marc Schwartz, PhD
Lombardi Cancer Research Center
United States: Food and Drug Administration