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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
Sponsor:
Collaborators:
National Cancer Institute (NCI)
North Carolina TraCS Institute
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

October 12, 2011
December 8, 2011
April 26, 2017
June 2012
February 27, 2014   (Final data collection date for primary outcome measure)
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.
Treatment Concordance [ Time Frame: Time of Surgery decision which is an average of 2-4 weeks before surgery. ]
We will assess patient preferences pre-operatively using conjoint analysis. We will determine if these preferences are concordant with the patient's treatment decision.
Complete list of historical versions of study NCT01488357 on ClinicalTrials.gov Archive Site
  • Body Image [ Time Frame: 18 months post operatively ]
    Body Image Scale
  • Satisfaction with Decisions [ Time Frame: 18 months post-operatively ]
    Satisfaction with Decisions Scale
  • Quality of Life [ Time Frame: 18 months post-operatively ]
    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. ]
    The investigator will use the Decision Quality Instrument which includes knowledge questions to assess patient understanding of breast reconstruction.
  • Body Image [ Time Frame: 18 months post operatively ]
    Body Image Scale
  • Satisfaction with Decisions [ Time Frame: 18 months post-operatively ]
    Satisfaction with Decisions Scale
  • Quality of Life [ Time Frame: 18 months post-operatively ]
    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. ]
    We will use the Decision Quality Instrument which includes knowledge questions to assess patient understanding of breast reconstruction.
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Patient Preferences for Breast Reconstruction After Mastectomy
Patient Preferences for Breast Reconstruction After Mastectomy
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Adult women undergoing mastectomy at UNC for treatment of Stage I, II, or III breast cancer or DCIS, or for prophylaxis
Breast Cancer
Not Provided
Early stage breast cancer patients receiving mastectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
145
133
June 30, 2016
February 27, 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01488357
11-0119
1K07CA154850-01A1 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
  • National Cancer Institute (NCI)
  • North Carolina TraCS Institute
Principal Investigator: Clara N Lee, MD, MPP Ohio State University
UNC Lineberger Comprehensive Cancer Center
April 2017