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.

Study Overview

• Status: Completed
• Conditions: Breast Surgery; Breast Cancer; Breast Augmentation; Breast Reconstruction; Breast Reduction
• Intervention / Treatment: Behavioral: questionnaires; Behavioral: questionnaires

• Study Type: Observational
• Enrollment (Actual): 722

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of British Columbia
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • John Hopkins Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States
      • Dartmouth Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • Pennsylvania
    • Pittsburg, Pennsylvania, United States
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinics at the various sites

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; Postoperative Breast Surgery Patients	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.
2; Preoperative Breast Surgery Patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To develop and validate a new patient derived measure of satisfaction with breast surgery.	conclusion of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Determining variations in satisfaction related to patient characteristics and preoperative expectations.	conclusion of study

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Johns Hopkins University; University of British Columbia; University of Pittsburgh; University College, London; McMaster University; Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Andrea Pusic, M.D., M.H.S., Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: June 1, 2005
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ACTUAL): November 1, 2013

Study Registration Dates

• First Submitted: January 11, 2008
• First Submitted That Met QC Criteria: January 30, 2008
• First Posted (ESTIMATE): January 31, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): November 14, 2013
• Last Update Submitted That Met QC Criteria: November 13, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 05-058