Status:
COMPLETED
Telephone-Based Genetic Counseling or Standard Genetic Counseling in Women at Risk of Carrying the BRCA1 or BRCA2 Mutation
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-85 years
Phase:
NA
Brief 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 ...
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/B...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
669 Patients enrolled
Trial Details
Trial ID
NCT00287898
Start Date
May 1 2005
End Date
January 1 2014
Last Update
April 7 2017
Active Locations (4)
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1
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
2
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
3
Mount Sinai School of Medicine
New York, New York, United States, 10029
4
Vermont Cancer Center at University of Vermont
Burlington, Vermont, United States, 05405-0110