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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00519974 |
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 | Intervention |
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Breast Cancer Cancer-Related Problem/Condition |
Procedure: counseling Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: study of socioeconomic and demographic variables |
Study Type: | Interventional |
Study Design: | Open Label |
Official Title: | Decision-Making About Breast Reconstruction After Mastectomy Among Ethnic Minority Women: An Exploratory Study of Qualitative Themes |
Estimated Enrollment: | 60 |
Study Start Date: | July 2007 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Have undergone mastectomy* (with or without reconstruction) for breast cancer within the past 3 years AND meets 1 of the following criteria:
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
Spirit of Hope or LatinaSHARE
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | Recruiting |
Ann Arbor, Michigan, United States, 48109-0942 | |
Contact: Clinical Trials Office - University of Michigan Comprehensive 800-865-1125 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: Andrea L. Pusic, MD, MHS 212-639-5085 pusica@mskcc.org | |
New School for Social Research | Recruiting |
New York, New York, United States, 10003 | |
Contact: Lisa Rubin, PhD 212-229-5700 | |
Spirit of Hope | Recruiting |
New York, New York, United States, 10030 | |
Contact: D.G. Wilson-Davis 917-507-4673 | |
SHARE, Incorporated | Recruiting |
New York, New York, United States, 10036 | |
Contact: Alice Yaker, JD 917-507-4673 | |
Ralph Lauren Center for Cancer Care and Prevention | Recruiting |
New York, New York, United States, 10035 | |
Contact: Contact Person 212-987-1777 |
Principal Investigator: | Andrea L. Pusic, MD, MHS | Memorial Sloan-Kettering Cancer Center |
Principal Investigator: | Karen Hurley, PhD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000561540, MSKCC-07087 |
Study First Received: | August 21, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00519974 |
Health Authority: | Unspecified |
psychosocial effects/treatment stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer recurrent breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |