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Clinical Trials/NCT00605670
NCT00605670
Completed
Not Applicable

Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument

Memorial Sloan Kettering Cancer Center5 sites in 2 countries722 target enrollmentJune 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
722
Locations
5
Primary Endpoint
To develop and validate a new patient derived measure of satisfaction with breast surgery.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The goal of this study is to develop a questionnaire to measure patient satisfaction with their breast surgery. This questionnaire will help surgeons better understand how patients feel about their surgical results. We hope that such a questionnaire will improve the understanding of breast surgery results and patient care.

Registry
clinicaltrials.gov
Start Date
June 2005
End Date
November 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • All stages (1-4)
  • Age \> or = to 18 to 85 years.
  • Postoperative Group: Male and Female patients who have undergone mastectomy, breast reconstruction, reduction, augmentation, bariatric or body contouring surgery between 1 month to 8 years ago
  • Preoperative Group: Male and Female patients who are scheduled to undergo mastectomy, breast reconstruction, reduction, or augmentation or body contouring surgery

Exclusion Criteria

  • Inability to speak or understand English
  • Active psychiatric illness, cognitive or sensory impairment
  • Physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions

Outcomes

Primary Outcomes

To develop and validate a new patient derived measure of satisfaction with breast surgery.

Time Frame: conclusion of study

Secondary Outcomes

  • Determining variations in satisfaction related to patient characteristics and preoperative expectations.(conclusion of study)

Study Sites (5)

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