Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery

This study has been completed.
Sponsor:
Collaborators:
McMaster University
University College, London
Dartmouth-Hitchcock Medical Center
University of British Columbia
Johns Hopkins University
University of Pittsburgh
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00605670
First received: January 11, 2008
Last updated: November 13, 2013
Last verified: November 2013

January 11, 2008
November 13, 2013
June 2005
November 2013   (final data collection date for primary outcome measure)
To develop and validate a new patient derived measure of satisfaction with breast surgery. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00605670 on ClinicalTrials.gov Archive Site
Determining variations in satisfaction related to patient characteristics and preoperative expectations. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery
Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Clinics at the various sites

  • Breast Cancer
  • Breast Surgery
  • Breast Reconstruction
  • Breast Reduction
  • Breast Augmentation
  • Behavioral: questionnaires
    patients will fill out two questionnaires post surgery
  • Behavioral: questionnaires
    Patient will fill out questionnaire before and 3 to 6 months after treatment.
  • 1
    Postoperative Breast Surgery Patients
    Intervention: Behavioral: questionnaires
  • 2
    Preoperative Breast Surgery Patients
    Intervention: Behavioral: questionnaires
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
722
November 2013
November 2013   (final data collection date for primary outcome measure)

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

Or

  • 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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00605670
05-058
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
  • McMaster University
  • University College, London
  • Dartmouth-Hitchcock Medical Center
  • University of British Columbia
  • Johns Hopkins University
  • University of Pittsburgh
Principal Investigator: Andrea Pusic, M.D., M.H.S. Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP