Patient Preferences for Breast Reconstruction After Mastectomy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
North Carolina TraCS Institute
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01488357
First received: October 12, 2011
Last updated: May 1, 2014
Last verified: April 2014
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Preferences for Breast Reconstruction After Mastectomy

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Treatment Concordance [ Time Frame: Time of Surgery decision which is an average of 2-4 weeks before surgery. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Body Image [ Time Frame: 18 months post operatively ] [ Designated as safety issue: No ]
    Body Image Scale

  • Satisfaction with Decisions [ Time Frame: 18 months post-operatively ] [ Designated as safety issue: No ]
    Satisfaction with Decisions Scale

  • Quality of Life [ Time Frame: 18 months post-operatively ] [ Designated as safety issue: No ]
    Breast-Q and Forecasting measures

  • Knowledge [ Time Frame: Pre-operatively at time of decision making which is an average of 2-4 weeks before surgery. ] [ Designated as safety issue: No ]
    The investigator will use the Decision Quality Instrument which includes knowledge questions to assess patient understanding of breast reconstruction.


Estimated Enrollment: 133
Study Start Date: June 2012
Estimated Study Completion Date: October 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Early stage breast cancer patients receiving mastectomy

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488357

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
North Carolina TraCS Institute
Investigators
Principal Investigator: Clara N Lee, MD, MPP University of North Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01488357     History of Changes
Other Study ID Numbers: 11-0119, 1K07CA154850-01A1
Study First Received: October 12, 2011
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
Breast cancer
UNC
Lineberger
Breast Reconstruction
Mastectomy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014