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

NCT ID: NCT00519974

Last Updated: 2015-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Breast Cancer Psychosocial Effects of Cancer and Its Treatment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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counseling intervention

Intervention Type OTHER

study of socioeconomic and demographic variables

Intervention Type OTHER

management of therapy complications

Intervention Type PROCEDURE

psychosocial assessment and care

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea L. Pusic, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Karen Hurley, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

New School for Social Research

New York, New York, United States

Site Status

Spirit of Hope

New York, New York, United States

Site Status

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States

Site Status

SHARE, Incorporated

New York, New York, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA008748

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MSKCC-07087

Identifier Type: -

Identifier Source: secondary_id

07-087

Identifier Type: -

Identifier Source: org_study_id

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