Decision-Making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00579007

Purpose

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.

Condition	Intervention
Breast Cancer Ovarian Cancer	Behavioral: telephone interviews

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Decision-Making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Genetic Counseling Mastectomy Ovarian Cancer Surgery

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	294
Study Start Date:	March 2003
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 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.

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women undergoing genetic counseling and testing for inherited breast or ovarian ccancer risk will be assessed before their first genetic counseling session

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579007

Contacts

Contact: Karen Hurley, Ph.D.

hurleyk@mskcc.org

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Karen Hurley, Ph.D. hurleyk@mskcc.org
Principal Investigator: Karen Hurley, Ph.D.

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Karen Hurley, Ph.D.

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Karen Hurley, PhD. )
Study ID Numbers:	03-001
Study First Received:	December 19, 2007
Last Updated:	June 2, 2009
ClinicalTrials.gov Identifier:	NCT00579007 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Prophylactic Mastectomy
Prophylactic Oophorectomy

Study placed in the following topic categories:

Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Urogenital Neoplasms

Ovarian Diseases
Genital Diseases, Female
Ovarian Cancer
Endocrinopathy
Breast Diseases
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Skin Diseases
Gonadal Disorders
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Urogenital Neoplasms

Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Breast Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009