Telephone-Based Genetic Counseling; An Equivalence Trial
- 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
- 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
PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months
Marc Schwartz, PhD
Lombardi Cancer Research Center
United States: Food and Drug Administration
|Mount Sinai School of Medicine||New York, New York 10029|
|Vermont Cancer Center at University of Vermont||Burlington, Vermont 05405-0075|
|Lombardi Comprehensive Cancer Center at Georgetown University Medical Center||Washington, District of Columbia 20007|
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|