The primary purpose of this study is to evaluate the effect of systematic identification and genetic counseling referral on rates of bilateral salpingo-oophorectomy (surgery to remove both fallopian tubes and ovaries) in women having mammograms at Swedish Medical Center in Seattle, WA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
458
The genetic counseling sessions are conducted by a licensed genetic counselor, certified by the American Board of Genetic Counseling and the American Board of Medical Genetics. This clinical counseling session may include, but is not limited to the following: 1. A review of medical and family history information to determine which genetic test (BRCA, HNPCC, p53, etc.), if any, is appropriate; 2. Discuss how the results - positive or negative - affect cancer risk 3. Discuss how cancer risk might be managed (surveillance, prophylactic surgery, oral contraceptives, etc.); 4. Discuss how the test is conducted and what the results might be (positive, negative, uncertain); 5. Discuss the disadvantages of genetic testing (cost, insurance coverage, worry about insurance discrimination, uncertain results, etc.) and the psychological and emotional issues surrounding testing, etc.
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms
Time frame: 24 months post-enrollment
Cancer related distress
Time frame: change from baseline at 12 and 24 months post-enrollment
Health-related quality of life
Time frame: change from baseline at 12 and 24 months post-enrollment
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