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

This study is currently recruiting participants.

Verified by Memorial Sloan-Kettering Cancer Center, June 2009

First Received: January 11, 2008 Last Updated: June 12, 2009 History of Changes

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center McMaster University University College, London Dartmouth-Hitchcock Medical Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00605670

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:	Cohort, 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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	610
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (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:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Clinics at the various sites

Criteria

Inclusion Criteria:

Female.
Age > or = to 18 to 85 years.
Postoperative Group: Patients who have undergone breast reconstruction, reduction or augmentation surgery between 1 to 8 years ago Or
Preoperative Group: Patients who are scheduled to undergo breast reconstruction, reduction or augmentation surgery

Exclusion Criteria:

Inability to speak or understand English

Contacts and Locations

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

Contacts

Contact: Andrea Pusic, MD		pusica@mskcc.org
Contact: Peter Cordeiro, MD		cordeirp@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Andrea Pusic, MD pusica@mskcc.org
Contact: Peter Cordeiro, MD cordeirp@mskcc.org
Principal Investigator: Andrea Pusic, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

McMaster University

University College, London

Dartmouth-Hitchcock Medical Center

Investigators

Principal Investigator:

Andrea Pusic, M.D., M.H.S.

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Andrea Pusic, M.D., M.H.S. )
Study ID Numbers:	05-058
Study First Received:	January 11, 2008
Last Updated:	June 12, 2009
ClinicalTrials.gov Identifier:	NCT00605670 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Quality of Life
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009