Standard Genetic Counseling With or Without a Decision Guide in Improving Communication Between Mothers Undergoing BRCA1/2 Testing and Their Minor-Age Children
Status: Recruiting
Phase: Phase 3
Diagnosis: Breast: Prevention
NCT ID: NCT00685256
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 07-406
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 children. PURPOSE: This randomized phase III trial is studying standard genetic counseling given together with a decision guide to see how well it works compared with genetic counseling alone in improving communication between mothers undergoing BRCA1/2 testing and their minor-age children.
Conducting Institutions:
Dana-Farber Cancer Institute, Children's Hospital Boston
Overall PI:
Andrea Patenaude, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Dana-Farber Cancer Institute:
Andrea Patenaude, 617-632-3314,
andrea_patenaude@dfci.harvard.edu
Eligibility Criteria
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