NCT Number: NCT00519974
Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
About this study
OBJECTIVES:
- Interview black and Latina women about their reasons for choosing to have, or not to have, breast reconstruction after mastectomy for breast cancer.
- Describe the context in which black and Latina women make decisions about breast reconstruction.
- Explore similarities and differences in factors affecting decision-making among black and Latina women.
- Identify factors that contribute to the low utilization of breast reconstruction among ethnic minority women.
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
- Have undergone mastectomy* (with or without reconstruction) for breast cancer within the past 3 years AND meets 1 of the following criteria:
- Self-identified as being black
- Self-identified as being Latina NOTE: *Patients scheduled to undergo mastectomy are eligible
- Recruited from one of the following cancer centers or breast cancer support organizations:
- Memorial Sloan-Kettering Cancer Center or Ralph Lauren Center for Cancer Care and Prevention
- Patients are identified by their physician (e.g., oncologist, breast surgeon), the protocol investigator, a member of the research team, and/or medical chart review
- Spirit of Hope or LatinaSHARE
- Patients are identified by the director of the support organization or the support group leader
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- No cognitive impairment that would preclude giving informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Treatment and study plan
study of socioeconomic and demographic variables
Othermanagement of therapy complications
Procedurepsychosocial assessment and care
ProcedurePrimary outcomes
-
Self-reported reasons among black and Latina women for choosing to have, or not to have, breast reconstruction after mastectomy
Time frame: 2 years
-
Development of a theoretical model that describes how black and Latina women make decisions regarding breast reconstruction after mastectomy
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Decision-Making About Breast Reconstruction After Mastectomy Among Ethnic Minority Women: An Exploratory Study of Qualitative Themes
Important dates
- Study start
- 2007
- Primary completion
- 2010
- Study completion
- 2010
- First posted
- Aug 23, 2007
- Registry last updated
- Oct 1, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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