Decision-making Regarding Prophylactic Mastectomy and Oophorectomy in Women Seeking Genetic Counseling and Testing for BRCA1/2 Mutations
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ClinicalTrials.gov Identifier: NCT00579007 |
Recruitment Status
:
Active, not recruiting
First Posted
: December 21, 2007
Last Update Posted
: April 4, 2018
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Condition or disease | Intervention/treatment |
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Breast Cancer Ovarian Cancer | Behavioral: telephone interviews |
Study Type : | Observational |
Actual Enrollment : | 224 participants |
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 |
Actual Study Start Date : | March 2003 |
Estimated Primary Completion Date : | March 2019 |
Estimated Study Completion Date : | March 2019 |
Group/Cohort | Intervention/treatment |
---|---|
1
Women with a strong family history of breast cancer.
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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.
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- 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 ]
- 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 ]

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Ages Eligible for Study: | 25 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579007
United States, New York | |
Memorial Sloan Kettering Cancer Center | |
New York, New York, United States, 10065 |
Principal Investigator: | Wendy Lichtenthal, Ph.D. | Memorial Sloan Kettering Cancer Center |
Additional Information:
Responsible Party: | Memorial Sloan Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00579007 History of Changes |
Other Study ID Numbers: |
03-001 |
First Posted: | December 21, 2007 Key Record Dates |
Last Update Posted: | April 4, 2018 |
Last Verified: | April 2018 |
Keywords provided by Memorial Sloan Kettering Cancer Center:
Prophylactic Mastectomy Prophylactic Oophorectomy |