Epithelial Ovarian Cancer
Conditions
Keywords
ovarian cancer, prevention, prophylactic surgery, risk, biomarkers, screening, symptoms
Brief summary
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.
Interventions
BEHAVIORALgenetic counseling
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.
Sponsors
Swedish Medical Center
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Prior mammogram at Swedish Medical Center * Willing and able to provide informed consent, primary physician information, and complete study questionnaires * Must meet at least ONE of the following criteria: * personal history of breast cancer diagnosed before age 50 * personal history of bilateral breast cancer at any age * 1 or more first degree relatives with breast cancer diagnosed before age 50 * 3 or more first or second degree relatives with breast cancer at any age * 2 second degree relatives with breast cancer diagnosed before age 50 * A male relative with breast cancer at any age * Ashkenazi Jewish with any family history of breast or ovarian cancer * 1 first or second degree relative with ovarian cancer AND 1 first or second degree relative with breast cancer at any age * 2 first degree relatives with ovarian cancer or 2 second degree relatives with ovarian cancer or 1 first and 1 second degree relative with ovarian cancer. * A first degree relative with both breast and ovarian cancer (2 primaries in the same person) * Personal history of positive genetic test result for any of the following genes: BRCA1, BRCA2, HNPCC, or P53 * Family history of a positive genetic test result for any of the following genes: BRCA1, BRCA2 or HNPCC
Exclusion criteria
* Previous diagnosis of ovarian cancer * Prior bilateral-salpingo oophorectomy * Had a negative genetic test result for a known family genetic mutation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms | 24 months post-enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Cancer related distress | change from baseline at 12 and 24 months post-enrollment |
| Health-related quality of life | change from baseline at 12 and 24 months post-enrollment |
Countries
United States
Outcome results
None listed