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Patient Preferences for Breast Reconstruction After Mastectomy

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ClinicalTrials.gov Identifier: NCT01488357
Recruitment Status : Completed
First Posted : December 8, 2011
Last Update Posted : April 26, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Breast Cancer

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.

Study Design

Study Type : Observational
Actual Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Preferences for Breast Reconstruction After Mastectomy
Study Start Date : June 2012
Primary Completion Date : February 27, 2014
Study Completion Date : June 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Early stage breast cancer patients receiving mastectomy

Outcome Measures

Primary Outcome Measures :
  1. Treatment Concordance [ Time Frame: Time 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 Outcome Measures :
  1. Body Image [ Time Frame: 18 months post operatively ]
    Body Image Scale

  2. Satisfaction with Decisions [ Time Frame: 18 months post-operatively ]
    Satisfaction with Decisions Scale

  3. Quality of Life [ Time Frame: 18 months post-operatively ]
    Breast-Q and Forecasting measures

  4. Knowledge [ Time Frame: Pre-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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01488357

United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
North Carolina TraCS Institute
Principal Investigator: Clara N Lee, MD, MPP Ohio State University
More Information

Additional Information:
Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01488357     History of Changes
Other Study ID Numbers: 11-0119
1K07CA154850-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 8, 2011    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017

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