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

Completed

• Conditions: Psychosocial Effects of Cancer and Its Treatment; Breast Cancer

• Registration Number: NCT00519974
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-23
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported reasons among black and Latina women for choosing to have, or not to have, breast reconstruction after mastectomy	2 years
Development of a theoretical model that describes how black and Latina women make decisions regarding breast reconstruction after mastectomy	2 years

Trial Locations

Locations (6)

New School for Social Research; 🇺🇸 New York, New York, United States

SHARE, Incorporated; 🇺🇸 New York, New York, United States

Ralph Lauren Center for Cancer Care and Prevention; 🇺🇸 New York, New York, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States

Spirit of Hope; 🇺🇸 New York, New York, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States