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

Completed

• Conditions: Breast Cancer; Breast Surgery; Breast Reconstruction; Breast Reduction; Breast Augmentation
• Interventions: Behavioral: questionnaires

• Registration Number: NCT00605670
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2008-01-11
• Study First Submitted QC: 2008-01-30
• Study First Posted: 2008-01-31
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-13
• Last Update Posted: 2013-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 722

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	questionnaires	Postoperative Breast Surgery Patients
2	questionnaires	Preoperative Breast Surgery Patients

Primary Outcome Measures

Name	Time	Method
To develop and validate a new patient derived measure of satisfaction with breast surgery.	conclusion of study

Secondary Outcome Measures

Name	Time	Method
Determining variations in satisfaction related to patient characteristics and preoperative expectations.	conclusion of study

Trial Locations

Locations (5)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

John Hopkins Medical Center; 🇺🇸 Baltimore, Maryland, United States

Dartmouth Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburg, Pennsylvania, United States

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada