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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579007
• Other study ID #: 03-001
• Status: Completed
• Start date: March 11, 2003
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2019
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 20, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Ovarian Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Memorial Sloan-Kettering Cancer Center