Status:
COMPLETED
Genetic Counseling or Usual Care in Helping Women With Newly Diagnosed Ductal Carcinoma In Situ or Stage I, Stage II, or Stage IIIA Breast Cancer Make Treatment Decisions
Lead Sponsor:
Georgetown University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Psychosocial Effects of Cancer and Its Treatment
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cance...
Detailed Description
OBJECTIVES: * Compare the impact of rapid genetic counseling (RGC) vs usual care on the medical decisions of women with newly diagnosed ductal carcinoma in situ or stage I-IIIA breast cancer. * Compa...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Newly diagnosed breast cancer, meeting 1 of the following criteria:
- Stage 0 disease (ductal carcinoma in situ only)
- Stage I-IIIA disease
- Must meet 1 of the following criteria:
- Diagnosis before 50 years of age
- Diagnosis after 50 years of age AND has 1 of the following:
- First or second degree relative diagnosed with breast cancer before 50 years of age
- First or second degree relative diagnosed with ovarian cancer at any age
- First or second degree relative diagnosed with male breast cancer at any age
- Must not have initiated definitive treatment for breast cancer
- No bilateral, metastatic, or inflammatory breast cancer
- No prior BRCA1/2 counseling or testing
- No prior diagnosis of metastatic cancer of any type
- Hormone receptor status:
- Not specified
- PATIENT CHARACTERISTICS:
- Sex
- Female
- Menopausal status
- Not specified
- Performance status
- Not specified
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Not specified
- Renal
- Not specified
- PRIOR CONCURRENT THERAPY:
- Surgery
- No prior bilateral mastectomy for breast cancer
- Other
- No concurrent treatment for cancer
Exclusion
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
331 Patients enrolled
Trial Details
Trial ID
NCT00262899
Start Date
August 1 2005
End Date
July 1 2011
Last Update
January 7 2013
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
Chevy Chase, Maryland, United States, 20815
3
Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, United States, 07601
4
Mount Sinai School of Medicine
New York, New York, United States, 10029