Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
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|ClinicalTrials.gov Identifier: NCT00287898|
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : April 7, 2017
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Behavioral: Telephone Genetic Counseling Behavioral: Usual Care|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||669 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Telephone-Based Genetic Counseling; An Equivalence Trial|
|Actual Study Start Date :||May 2005|
|Primary Completion Date :||December 2012|
|Study Completion Date :||January 2014|
Experimental: Telephone Genetic Counseling
Participants randomized to this arm will receive all genetic counseling via telephone.
Behavioral: Telephone Genetic Counseling
Participants will receive all genetic counseling via telephone
Active Comparator: Usual Care
Participants randomized to usual care will receive standard in-person genetic counseling.
Behavioral: Usual Care
subjects will receive standard in-person genetic counseling
- Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months [ Time Frame: 6 months ]
- Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months [ Time Frame: 3 months ]
- Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months [ Time Frame: 3 months ]
- Quality of life as assessed by SF-12 health survey at 3 and 6 months [ Time Frame: 6 months ]
- Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months [ Time Frame: 6 months ]
- Costs by cost measurement post-counseling [ Time Frame: 6 months ]
- Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Comprehensive Cancer Center|