|
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center MOUNT SINAI HOSPITAL Georgetown University U.S. Army Medical Research and Materiel Command |
Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00579007 |
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 |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer Genetic Counseling Mastectomy Ovarian Cancer |
ChemIDplus related topics: | BaseLine |
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 |
Estimated Enrollment: | 294 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | March 2010 |
Estimated Primary Completion Date: | March 2009 (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.
|
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.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Women undergoing genetic counseling and testing for inherited breast or ovarian ccancer risk will be assessed before their first genetic counseling session
Inclusion Criteria:
Exclusion Criteria:
Contact: Karen Hurley, Ph.D. | hurleyk@mskcc.org |
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. |
Memorial Sloan-Kettering Cancer Center |
MOUNT SINAI HOSPITAL |
Georgetown University |
U.S. Army Medical Research and Materiel Command |
Principal Investigator: | Karen Hurley, Ph.D. | Memorial Sloan-Kettering Cancer Center |
Memorial Sloan-Kettering Cancer Center 
  |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Karen Hurley, PhD. ) |
Study ID Numbers: | 03-001 |
First Received: | December 19, 2007 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00579007 |
Health Authority: | United States: Institutional Review Board |
|
|
|
|