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Clinical Trials/NCT01488357
NCT01488357
Completed
Not Applicable

Patient Preferences for Breast Reconstruction After Mastectomy

UNC Lineberger Comprehensive Cancer Center1 site in 1 country145 target enrollmentJune 2012
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
UNC Lineberger Comprehensive Cancer Center
Enrollment
145
Locations
1
Primary Endpoint
Treatment Concordance
Status
Completed
Last Updated
9 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
June 30, 2016
Last Updated
9 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Treatment Concordance

Time Frame: Time of Surgery decision which is an average of 2-4 weeks before surgery.

The investigator will assess patient preferences pre-operatively using conjoint analysis. The investigator will determine if these preferences are concordant with the patient's treatment decision.

Secondary Outcomes

  • Satisfaction with Decisions(18 months post-operatively)
  • Knowledge(Pre-operatively at time of decision making which is an average of 2-4 weeks before surgery.)
  • Body Image(18 months post operatively)
  • Quality of Life(18 months post-operatively)

Study Sites (1)

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