Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations
RATIONALE: Genetic counseling and using an interactive computer program may help women at risk for breast cancer make medical decisions about treatment.
PURPOSE: This randomized clinical trial is studying standard genetic counseling to see how well it works when given together with or without a medical decision-making computer program in women at risk for BRCA1 or BRCA2 mutations.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
|Official Title:||Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing|
- patient satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]subjects will complete questionnaires re; genetic counseling experience
|Study Start Date:||December 2000|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Other: counseling intervention
- 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.
Outcome assessments, including quality of life assessment, are conducted at 2, 6, and 12 months.
PROJECTED ACCRUAL: A total of 950 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416754
|Principal Investigator:||Marc Schwartz, PhD||Lombardi Comprehensive Cancer Center|