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
  Purpose

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.


Condition Intervention
Breast Cancer
Breast Surgery
Breast Reconstruction
Breast Reduction
Breast Augmentation
Behavioral: questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To develop and validate a new patient derived measure of satisfaction with breast surgery. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determining variations in satisfaction related to patient characteristics and preoperative expectations. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Enrollment: 722
Study Start Date: June 2005
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Postoperative Breast Surgery Patients
Behavioral: questionnaires
patients will fill out two questionnaires post surgery
2
Preoperative Breast Surgery Patients
Behavioral: questionnaires
Patient will fill out questionnaire before and 3 to 6 months after treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinics at the various sites

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605670

Locations
United States, Maryland
John Hopkins Medical Center
Baltimore, Maryland, United States, 21287
United States, New Hampshire
Dartmouth Medical Center
Lebanon, New Hampshire, United States
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburg, Pennsylvania, United States
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
McMaster University
University College, London
Dartmouth-Hitchcock Medical Center
University of British Columbia
Johns Hopkins University
University of Pittsburgh
Investigators
Principal Investigator: Andrea Pusic, M.D., M.H.S. Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00605670     History of Changes
Other Study ID Numbers: 05-058
Study First Received: January 11, 2008
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014