Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations|
- 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). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- To determine the relative contributions of sociodemographic, medical, and psychosocial factors to stage of intention regarding prophylactic mastectomy and/or oophorectomy. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Women with a strong family history of breast cancer.
Behavioral: telephone interviews
Telephone interviews take place before the first counseling appointment (baseline), and 1 week, 6 months and 12 months post-notification of the individual's genetic test results. In the event that a participant chooses not to undergo genetic testing, follow-up interviews will take place 1 month, 6 months and 12 months after the initial counseling visit.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579007
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Wendy Lichtenthal, Ph.D.||Memorial Sloan Kettering Cancer Center|