NCT00287898

Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation

Telephone-Based Genetic Counseling; An Equivalence Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 669 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Telephone Genetic Counseling	Participants will receive all genetic counseling via telephone
BEHAVIORAL	Usual Care	subjects will receive standard in-person genetic counseling

Timeline

• Start date: 2005-05-01
• Primary completion: 2012-12-01
• Completion: 2014-01-01
• First posted: 2006-02-07
• Last updated: 2017-04-07

Locations

4 sites across 1 country: United States