Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women
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| First Received Date ICMJE | August 21, 2007 | ||||||||
| Last Updated Date | March 15, 2013 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00519974 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women | ||||||||
| Official Title ICMJE | Decision-Making About Breast Reconstruction After Mastectomy Among Ethnic Minority Women: An Exploratory Study of Qualitative Themes | ||||||||
| Brief Summary | RATIONALE: Learning about the reasons for choosing to have, or not to have, breast reconstruction after mastectomy for breast cancer may help doctors understand why black or Latina women may or may not undergo breast reconstruction. PURPOSE: This clinical trial is studying factors affecting decisions about breast reconstruction after mastectomy in black and Latina women. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a multicenter study. Patients undergo a 1-hour interview to evaluate their rationale for choosing to have, or not to have, breast reconstruction after mastectomy. Interviews are conducted by a woman of the same ethnic background as the patient. Key factors influencing a patient's decision to consider having breast reconstruction are explored during the interview, including availability of educational materials on breast reconstruction and the adequacy of this information. Patients are asked to examine personal factors influencing their decision, such as feelings about living with or without a reconstructed breast; concerns about reconstructive surgery and its risks; potential complications; and impact of reconstructive surgery on sexuality and body image. Social and cultural factors are also evaluated, including influence of family and friends; degree of support for the patient's decision to have surgery; racial or ethnic differences in patient's preferences; and cultural values. Access-related factors, such as financial cost, insurance availability, or physician referral practices, are also explored. At the end of the interview, patients may be referred to Memorial Sloan-Kettering Cancer Center or Ralph Lauren Center for Cancer Care and Prevention for oncologic surveillance or for additional information on breast reconstruction. Patients may also be contacted after the interview to answer follow-up questions, to clarify topics previously discussed, or to provide further input or feedback on preliminary study findings. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Black and Latina female breast cancer patients who have undergone or scheduled to undergo mastectomy within the past 3 years will be identified by their physicians (e.g., medical oncologists, breast surgeon, plastic surgeon) at MSKCC and RLCCCP or by the advocacy center to which they belong. |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 55 | ||||||||
| Completion Date | June 2010 | ||||||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Female | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00519974 | ||||||||
| Other Study ID Numbers ICMJE | 07-087, P30CA008748, MSKCC-07087 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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