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Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00519974
  Purpose

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
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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Breast Reconstruction Cancer Mastectomy
U.S. FDA Resources
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Self-reported reasons among black and Latina women for choosing to have, or not to have, breast reconstruction after mastectomy [ Designated as safety issue: No ]
  • Development of a theoretical model that describes how black and Latina women make decisions regarding breast reconstruction after mastectomy [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519974

Locations
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        
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Andrea L. Pusic, MD, MHS Memorial Sloan-Kettering Cancer Center
Principal Investigator: Karen Hurley, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000561540, MSKCC-07087
Study First Received: August 21, 2007
Last Updated: December 16, 2008
ClinicalTrials.gov Identifier: NCT00519974  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Skin Diseases
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 15, 2009