Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00519974|
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : October 1, 2015
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Psychosocial Effects of Cancer and Its Treatment||Other: counseling intervention Other: study of socioeconomic and demographic variables Procedure: management of therapy complications Procedure: psychosocial assessment and care|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||55 participants|
|Official Title:||Decision-Making About Breast Reconstruction After Mastectomy Among Ethnic Minority Women: An Exploratory Study of Qualitative Themes|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
- 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 ]
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): NCT00519974
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|United States, New York|
|New School for Social Research|
|New York, New York, United States, 10003|
|Spirit of Hope|
|New York, New York, United States, 10030|
|Ralph Lauren Center for Cancer Care and Prevention|
|New York, New York, United States, 10035|
|New York, New York, United States, 10036|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Andrea L. Pusic, MD, MHS||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Karen Hurley, PhD||Memorial Sloan Kettering Cancer Center|