or
forgot password

Patient Preferences for Breast Reconstruction After Mastectomy


N/A
21 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Patient Preferences for Breast Reconstruction After Mastectomy


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Treatment Concordance

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Clara N Lee, MD, MPP

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina

Authority:

United States: Institutional Review Board

Study ID:

11-0119

NCT ID:

NCT01488357

Start Date:

June 2012

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • UNC
  • Lineberger
  • Breast Reconstruction
  • Mastectomy
  • Breast Neoplasms

Name

Location

University of North Carolina Chapel Hill, North Carolina  27599