Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
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.
Genetic: mutation analysis
Other: counseling intervention
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Telephone-Based Genetic Counseling; An Equivalence Trial|
- Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Quality of life as assessed by SF-12 health survey at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Costs by cost measurement post-counseling [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: mutation analysis and counseling intervention
blood specimens will be collected for mutation analysis and subjects will receive genetic counseling
Genetic: mutation analysis
Blood specimen will be analyzed for gene mutationsOther: counseling intervention
subjects will receive genetic counseling
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287898
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center|
|Washington, District of Columbia, United States, 20007|
|United States, Massachusetts|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115-6084|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029|
|United States, Vermont|
|Vermont Cancer Center at University of Vermont|
|Burlington, Vermont, United States, 05405-0110|
|Study Chair:||Marc Schwartz, PhD||Lombardi Cancer Research Center|