This trial is active, not recruiting.

Condition breast cancer
Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 2012
End date February 2014
Trial size 145 participants
Trial identifier NCT01488357, 11-0119, 1K07CA154850-01A1


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Treatment Concordance
time frame: Time of Surgery decision which is an average of 2-4 weeks before surgery.

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 21 years old.

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

Additional Information

Official title Patient Preferences for Breast Reconstruction After Mastectomy
Principal investigator Clara N Lee, MD, MPP
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.