Skip to content

Patient Preferences for Breast Reconstruction After Mastectomy

Patient Preferences for Breast Reconstruction After Mastectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01488357
Enrollment
145
Registered
2011-12-08
Start date
2012-06-30
Completion date
2016-06-30
Last updated
2017-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, UNC, Lineberger, Breast Reconstruction, Mastectomy

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.

Interventions

None listed

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
North Carolina TraCS Institute
CollaboratorUNKNOWN
UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment ConcordanceTime 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

MeasureTime frameDescription
Body Image18 months post operativelyBody Image Scale
Satisfaction with Decisions18 months post-operativelySatisfaction with Decisions Scale
Quality of Life18 months post-operativelyBreast-Q and Forecasting measures
KnowledgePre-operatively at time of decision making which is an average of 2-4 weeks before surgery.The investigator will use the Decision Quality Instrument which includes knowledge questions to assess patient understanding of breast reconstruction.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026