Patient Preferences for Breast Reconstruction After Mastectomy

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

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.

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult women undergoing mastectomy at UNC for treatment of Stage I, II, or III breast cancer or DCIS, or for prophylaxis

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Early stage breast cancer patients receiving mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Concordance	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.	Time of Surgery decision which is an average of 2-4 weeks before surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Image	Body Image Scale	18 months post operatively
Satisfaction with Decisions	Satisfaction with Decisions Scale	18 months post-operatively
Quality of Life	Breast-Q and Forecasting measures	18 months post-operatively
Knowledge	The investigator will use the Decision Quality Instrument which includes knowledge questions to assess patient understanding of breast reconstruction.	Pre-operatively at time of decision making which is an average of 2-4 weeks before surgery.

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); North Carolina TraCS Institute
• Investigators: Principal Investigator: Clara N Lee, MD, MPP, Ohio State University

Publications and helpful links

Helpful Links

• National Cancer Institute
• UNC Lineberger Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): February 27, 2014
• Study Completion (Actual): June 30, 2016

Study Registration Dates

• First Submitted: October 12, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 8, 2011

Study Record Updates

• Last Update Posted (Actual): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Breast cancer; Mastectomy; Breast Reconstruction; Lineberger; UNC
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 11-0119; 1K07CA154850-01A1 (U.S. NIH Grant/Contract)