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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605670
• Other study ID #: 05-058
• Status: Completed
• Phase: N/A
• First received: January 11, 2008
• Last updated: November 13, 2013
• Start date: June 2005
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 722
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Cancer
• Breast Reconstruction
• Breast Reduction
• Breast Surgery

Intervention

Behavioral:
• questionnaires
patients will fill out two questionnaires post surgery
• questionnaires
Patient will fill out questionnaire before and 3 to 6 months after treatment.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
United States	John Hopkins Medical Center	Baltimore	Maryland
United States	Dartmouth Medical Center	Lebanon	New Hampshire
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburg	Pennsylvania

Sponsors (7)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Dartmouth-Hitchcock Medical Center, Johns Hopkins University, McMaster University, University College, London, University of British Columbia, University of Pittsburgh

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To develop and validate a new patient derived measure of satisfaction with breast surgery.		conclusion of study	No
Secondary	Determining variations in satisfaction related to patient characteristics and preoperative expectations.		conclusion of study	No

External Links

•   Memorial Sloan-Kettering Cancer Center