Prevention of Ovarian Cancer in Women Participating in Mammography

Study Overview
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Brief Summary
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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.

Official Title
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Prevention of Ovarian Cancer in Women Participating in Mammography

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Behavioral: genetic counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Genetic counseling<br>After randomization the participant is offered a referral to a genetic counselor. | Behavioral: genetic counseling<br>* 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: A review of medical and family history information to determine which genetic test (BRCA, HNPCC, p53, etc.), if any, is appropriate; Discuss how the results - positive or negative - affect cancer risk Discuss how cancer risk might be managed (surveillance, prophylactic surgery, oral contraceptives, etc.); Discuss how the test is conducted and what the results might be (positive, negative, uncertain); 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms |  | 24 months post-enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian cancer, prevention, prophylactic surgery, risk, biomarkers, screening, symptoms