This trial is active, not recruiting.

Condition breast cancer
Treatments mutation analysis, counseling intervention
Phase phase 3
Sponsor Georgetown University
Collaborator National Cancer Institute (NCI)
Start date May 2005
End date December 2015
Trial size 600 participants
Trial identifier NCT00287898, CDR0000450959, GUMC-2004-133, P30CA051008, R01CA082346, R01CA108933


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Female participants from 21 years up to 85 years old.

DISEASE CHARACTERISTICS: - Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following: - First-degree relative of affected family member with a 50% chance of inheriting a BRCA1/BRCA2 mutation - Second-degree relative with BRCA1/BRCA2 mutation with 25% risk of inheritance (parent deceased) - Obligate gene carrier or affected woman - Must live within 100 miles of the Lombardi Comprehensive Cancer Center - No more than 4 weeks since breast or ovarian cancer diagnosis - No metastatic or inflammatory breast cancer or ovarian cancer - No stage III breast or ovarian cancer while undergoing concurrent chemotherapy PATIENT CHARACTERISTICS: - No psychiatric illness or cognitive disorder that would preclude informed consent PRIOR CONCURRENT THERAPY: - No prior genetic counseling or testing for BRCA1 and/or BRCA2

Additional Information

Official title Telephone-Based Genetic Counseling; An Equivalence Trial
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Georgetown University.