Prevention of Ovarian Cancer in Women Participating in Mammography
Not Applicable
Completed
- Conditions
- Epithelial Ovarian Cancer
- Interventions
- Behavioral: genetic counseling
- Registration Number
- NCT01851109
- Lead Sponsor
- Fred Hutchinson Cancer Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 458
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genetic counseling genetic counseling After randomization the participant is offered a referral to a genetic counselor.
- Primary Outcome Measures
Name Time Method Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms 24 months post-enrollment
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States