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

September 29, 2015 updated by: Memorial Sloan Kettering Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self-reported reasons among black and Latina women for choosing to have, or not to have, breast reconstruction after mastectomy
Time Frame: 2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Karen Hurley, PhD, Memorial Sloan Kettering Cancer Center
  • Principal Investigator: Andrea L. Pusic, MD, MHS, Memorial Sloan Kettering Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

August 21, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 23, 2007

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-087
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-07087

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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