Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations

Completed

• Conditions: Ovarian Cancer; Breast Cancer
• Interventions: Behavioral: telephone interviews

• Registration Number: NCT00579007
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to learn more about women's decision to undergo prophylactic surgery. This is removal of healthy organs in order to reduce risk of cancer. This study will help us to understand what makes women decide whether or not to have this kind of surgery.

Detailed Description

For women with a strong family history of breast/ovarian cancer, few options exist for primary prevention of these cancers other than prophylactic surgery, or surgical removal of noncancerous organs in order to prevent occurrence of the disease. The primary aim of the study is to describe the stages of intention to undergo prophylactic mastectomy and/or oophorectomy among women seeking genetic testing for inherited BRCA1 and BRCA2 mutations, and to identify factors that influence stages of intention regarding prophylactic surgery. To achieve these aims, 626 women undergoing genetic counseling and testing for inherited breast ovarian cancer risk will be assessed before their first genetic counseling session and three times (1 week, 6 months and 12 months) in the year following notification of their genetic test results.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2003-03-11
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-20
• Study First Posted: 2007-12-21
• Status Verified: 2019-11
• Primary Completion: 2019-11-20
• Study Completion: 2019-11-20
• Last Update Submitted: 2019-11-20
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

Inclusion Criteria

• Female gender
• age 25 and above
• a personal or family history of breast and/or ovarian cancer showing clinical features associated with increased risk of carrying a BRCA1/2 mutation (e.g., breast and ovarian cancer on the same side of the family, early age of onset, multiple primaries in the same individual) or having a first-degree relative with a known BRCA1 or BRCA2 mutation.

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Exclusion Criteria

• Male gender
• age less than 25 years
• unable to provide meaningful informed consent due to physical, cognitive or psychiatric disability
• non-English speaking

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	telephone interviews	Women with a strong family history of breast cancer.

Primary Outcome Measures

Name	Time	Method
Primary outcome of the study is stage of intention to undergo prophylactic surgery. Outcome variable consists of 6 rank-ordered, qualitatively distinct stages (see Measures) ranging from Precontemplation (no intention) to Action (intention carried out).	1 year

Secondary Outcome Measures

Name	Time	Method
To determine the relative contributions of sociodemographic, medical, and psychosocial factors to stage of intention regarding prophylactic mastectomy and/or oophorectomy.	conclusion of the study

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States