Status:
COMPLETED
Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
Conditions:
Breast Cancer
Hereditary Breast/Ovarian Cancer (brca1, brca2)
Eligibility:
FEMALE
8-120 years
Phase:
PHASE3
Brief Summary
RATIONALE: A study that evaluates the support of a decision guide used together with genetic counseling may improve communication between mothers undergoing BRCA1/2 testing and their minor-age childre...
Detailed Description
OBJECTIVES: Primary * To evaluate the efficacy of a decision support intervention delivered in conjunction with standard genetic counseling compared to standard genetic counseling alone in improving...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Mothers self-identified as primary caregivers to minor-age children (ages 8-21 years-old)
- Mothers must be undergoing genetic counseling and have provided a blood sample for analysis for BRCA1/2 mutations
- Mothers must have resided in the same home as the child(ren) for the past 6 months and intend to continue to reside with the child(ren) for the next 6 months
- PATIENT CHARACTERISTICS:
- At least 21 years old (mothers)
- No serious mental illness (e.g., cognitive and psychotic disorders) or developmental disability that would limit participation or preclude informed consent
- Must be able to adequately understand, speak, and read English
- Must have ready and consistent access to a telephone
- PRIOR CONCURRENT THERAPY:
- Not specified
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00685256
Start Date
March 1 2008
End Date
December 1 2015
Last Update
May 17 2017
Active Locations (2)
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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