Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00519974
First received: August 21, 2007
Last updated: March 15, 2013
Last verified: March 2013

August 21, 2007
March 15, 2013
July 2007
June 2010   (final data collection date for primary outcome measure)
  • Self-reported reasons among black and Latina women for choosing to have, or not to have, breast reconstruction after mastectomy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Development of a theoretical model that describes how black and Latina women make decisions regarding breast reconstruction after mastectomy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Self-reported reasons among Black and Latina women for choosing to have, or not to have, breast reconstruction
  • Development of a theoretical model that describes how Black and Latina women make decisions regarding breast reconstruction
Complete list of historical versions of study NCT00519974 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Factors Affecting Decisions About Breast Reconstruction After Mastectomy in Black and Latina Women
Decision-Making About Breast Reconstruction After Mastectomy Among Ethnic Minority Women: An Exploratory Study of Qualitative Themes

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00519974
07-087, P30CA008748, MSKCC-07087
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Andrea L. Pusic, MD, MHS Memorial Sloan-Kettering Cancer Center
Principal Investigator: Karen Hurley, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP