Prevention of Ovarian Cancer in Women Participating in Mammography

NCT ID: NCT01851109

Last Updated: 2016-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2015-12-31

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.

Conditions

Epithelial Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Genetic counseling

After randomization the participant is offered a referral to a genetic counselor.

Group Type: EXPERIMENTAL

genetic counseling

Intervention Type: BEHAVIORAL

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.

Interventions

genetic 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Swedish Medical Center

OTHER

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicole Urban, ScD

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

1R18DP001142-01

Identifier Type: NIH

Identifier Source: org_study_id

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