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Telephone-Based Genetic Counseling; An Equivalence Trial
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.
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.
Age
21 - 85 years
Sex
FEMALE
Healthy Volunteers
No
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mount Sinai School of Medicine
New York, New York, United States
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States
Start Date
May 1, 2005
Primary Completion Date
December 1, 2012
Completion Date
January 1, 2014
Last Updated
April 7, 2017
669
ACTUAL participants
Telephone Genetic Counseling
BEHAVIORAL
Usual Care
BEHAVIORAL
Lead Sponsor
Georgetown University
Collaborators
NCT05245812
NCT05372640
Data Source & Attribution
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