Prevention of Ovarian Cancer in Women Participating in Mammography

NCT01851109 | Completed

• 1 other identifier: 1R18DP001142-01
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

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

Keywords

ovarian cancer; prevention; prophylactic surgery; risk; biomarkers; screening; symptoms

Outcome Measures

Primary Outcomes (1)

• Compare rates of risk-reducing salpingo-oophorectomy in each of the study arms

  24 months post-enrollment

Secondary Outcomes (2)

• 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

Study Arms (2)

Control

NO INTERVENTION

Genetic counseling

EXPERIMENTAL

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

Behavioral: genetic counseling

Interventions

genetic counseling 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.

Genetic counseling

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• or more first degree relatives with breast cancer diagnosed before age 50
• or more first or second degree relatives with breast cancer at any age
• 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
• first or second degree relative with ovarian cancer AND 1 first or second degree relative with breast cancer at any age
• 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

You may not qualify if:

• Previous diagnosis of ovarian cancer
• Prior bilateral-salpingo oophorectomy
• Had a negative genetic test result for a known family genetic mutation

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Swedish Medical Center: collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Ovarian Neoplasms

Interventions

Genetic Counseling

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Genetic Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nicole Urban, ScD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 10, 2013
• Study Start: July 1, 2008
• Primary Completion: May 1, 2013
• Study Completion: December 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

US (1)