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:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579007
First received: December 19, 2007
Last updated: April 28, 2016
Last verified: April 2016
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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:
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 2017 |
| Estimated Primary Completion Date: | March 2017 (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 (Adult, Senior) |
| 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
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:
| 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: | April 28, 2016 |
| 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 September 23, 2016