Clinical Trials Directory

Trials / Completed

CompletedNCT01488357

Patient Preferences for Breast Reconstruction After Mastectomy

Status
Completed
Phase
Study type
Observational
Enrollment
145 (actual)
Sponsor
UNC Lineberger Comprehensive Cancer Center · Academic / Other
Sex
Female
Age
21 Years
Healthy volunteers
Not accepted

Summary

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

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

Timeline

Start date
2012-06-01
Primary completion
2014-02-27
Completion
2016-06-30
First posted
2011-12-08
Last updated
2017-04-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01488357. Inclusion in this directory is not an endorsement.