Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center.
ClinicalTrials.gov Identifier:
NCT00579007
First received: December 19, 2007
Last updated: December 4, 2014
Last verified: December 2014
History of Changes
  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: 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

Resource links provided by NLM:

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 ]
Enrollment: 224
Study Start Date: March 2003
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center.
Investigators
Principal Investigator: Wendy Lichtenthal, 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.
ClinicalTrials.gov Identifier: NCT00579007     History of Changes
Other Study ID Numbers: 03-001
Study First Received: December 19, 2007
Last Updated: December 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan Kettering Cancer Center.:
Prophylactic Mastectomy
Prophylactic Oophorectomy

ClinicalTrials.gov processed this record on February 27, 2015