Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Usual CareBehavioral: Telephone Genetic Counseling
- Registration Number
- NCT00287898
- Lead Sponsor
- Georgetown University
- Brief Summary
RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
- Detailed Description
OBJECTIVES:
Primary
* Compare the impact of telephone genetic counseling (TGC) versus standard genetic counseling (SGC) on utilization of BRCA1/BRCA2 testing in women at risk of carrying the BRCA1/BRCA2 mutation.
* Compare the relative efficacy of TGC versus SGC on satisfaction with the counseling process, informed decision making, psychosocial distress, and quality of life.
Secondary
* Identify participant characteristics that predict differential response to TGC.
* Explore the mechanisms by which TGC or SGC impact distress and quality of life.
OUTLINE: This is a randomized, multicenter study. Participants are stratified according to participating site. Participants are randomized to 1 of 2 groups.
* Group 1 (standard genetic counseling): Participants undergo an in-person genetic counseling session. Participants are then given the option of providing blood for genetic testing at the study site. Participants who choose to undergo genetic testing receive their results in-person from their genetic counselor.
* Group 2 (telephone-based genetic counseling): Participants undergo a telephone-based genetic counseling session. Participants who choose to undergo genetic testing receive a pre-labeled blood kit in the mail. Participants receive their results over the phone from their genetic counselor.
After completion of genetic counseling, all participants are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 669
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual Care Participants randomized to usual care will receive standard in-person genetic counseling. Telephone Genetic Counseling Telephone Genetic Counseling Participants randomized to this arm will receive all genetic counseling via telephone.
- Primary Outcome Measures
Name Time Method Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months 6 months Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months 3 months Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months 3 months Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months 6 months Quality of life as assessed by SF-12 health survey at 3 and 6 months 6 months
- Secondary Outcome Measures
Name Time Method Costs by cost measurement post-counseling 6 months Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months 12 months
Trial Locations
- Locations (4)
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Vermont Cancer Center at University of Vermont
🇺🇸Burlington, Vermont, United States