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
  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
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Decision-Making About Breast Reconstruction After Mastectomy Among Ethnic Minority Women: An Exploratory Study of Qualitative Themes

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: July 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (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
Sampling Method:   Non-Probability Sample
Study Population

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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
New School for Social Research
New York, New York, United States, 10003
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, United States, 10035
SHARE, Incorporated
New York, New York, United States, 10036
Spirit of Hope
New York, New York, United States, 10030
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

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00519974     History of Changes
Other Study ID Numbers: 07-087, P30CA008748, MSKCC-07087
Study First Received: August 21, 2007
Last Updated: March 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
psychosocial effects of cancer and its 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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 29, 2014