Genetic Counseling in Women at Risk for BRCA1 or BRCA2 Mutations
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|ClinicalTrials.gov Identifier: NCT00416754|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : April 7, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: counseling intervention||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1109 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Improving the Long-Term Outcomes of BRCA1/BRCA2 Mutation Testing|
|Study Start Date :||December 2000|
|Actual Primary Completion Date :||December 2006|
|Actual Study Completion Date :||December 2006|
Other: counseling intervention
- patient satisfaction [ Time Frame: 1 year ]subjects will complete questionnaires re; genetic counseling experience
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416754
|Principal Investigator:||Marc Schwartz, PhD||Lombardi Comprehensive Cancer Center|