CompletedNot Applicable

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

United States224 participantsStarted 2003-03-11

Plain-language 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.

Who can participate

Age range25 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. 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

What they're measuring

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).

Timeframe: 1 year

Trial details

NCT IDNCT00579007

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-11-20

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