Patient Preferences for Breast Reconstruction After Mastectomy

NCT ID: NCT01488357

Last Updated: 2017-04-26

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

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-06-30

Brief Summary

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Deciding whether or not to have breast reconstruction after mastectomy is highly challenging for many patients. This study will examine patients' decisions about reconstruction and the effects of reconstruction on quality of life and body image.

Detailed Description

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Breast reconstruction after mastectomy is an important treatment option for the many thousands of women who undergo mastectomy each year. Its insurance coverage is mandated by federal law. Many women who want reconstruction, particularly women from racial and ethnic minorities, never receive it, and some women who undergo reconstruction regret having it, raising concern about the quality of decisions about the procedure. Little is known about the quality of breast reconstruction decisions, defined as the extent to which decisions are informed and concordant with patients' preferences. A lack of reliable methods for evaluating preference concordance has resulted in a paucity of research in this area. Deciding about breast reconstruction requires a patient to predict how she would feel after the procedure, a process called affective forecasting. Extensive psychological research has shown that people have difficulty making accurate predictions about how they will feel, tending to overestimate the effects of disease and treatments on their well-being and to underestimate their ability to adapt to change and the effects of other aspects of their lives. Despite the importance of affective forecasting to decisions about breast reconstruction, no research has examined this aspect of those decisions. The investigator proposes to conduct a pilot cohort study of breast cancer patients undergoing mastectomy, with or without reconstruction with the following specific aims: Aim 1: to evaluate whether patients make informed decisions about breast reconstruction that are concordant with their preferences; Aim 2: to assess the accuracy of patients' preoperative predictions about their post-operative body image and well-being; and Aim 3: to assess the effects of breast reconstruction on quality of life and body image and the potential modification of those effects by preference concordance.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early stage breast cancer patients receiving mastectomy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Women 21 years of age or older
* Having a mastectomy at UNC for treatment of Stage I, II, or III breast cancer, ductal carcinoma in situ (DCIS) or for prophylaxis

Exclusion Criteria

* Stage IV breast cancer
* Women who do not speak English
* Severe psychiatric illness
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

North Carolina TraCS Institute

UNKNOWN

Sponsor Role collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clara N Lee, MD, MPP

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Countries

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United States

Related Links

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http://www.cancer.gov/

National Cancer Institute

http://cancer.unc.edu/

UNC Lineberger Comprehensive Cancer Center

Other Identifiers

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1K07CA154850-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11-0119

Identifier Type: -

Identifier Source: org_study_id

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