Patient Preferences for Breast Reconstruction After Mastectomy

Breast Cancer Clinical Trial

Official title:

Patient Preferences for Breast Reconstruction After Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01488357
• Other study ID #: 11-0119
• Secondary ID: 1K07CA154850-01A
• Status: Completed
• Phase: N/A
• First received: October 12, 2011
• Last updated: April 25, 2017
• Start date: June 2012
• Est. completion date: June 30, 2016

Study information

• Verified date: April 2017
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: June 30, 2016
• Est. primary completion date: February 27, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI), North Carolina TraCS Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Body Image	Body Image Scale	18 months post operatively
Secondary	Satisfaction with Decisions	Satisfaction with Decisions Scale	18 months post-operatively
Secondary	Quality of Life	Breast-Q and Forecasting measures	18 months post-operatively
Secondary	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.

External Links

•   National Cancer Institute
•   UNC Lineberger Comprehensive Cancer Center