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

NCT00605670 | Completed

• 1 other identifier: 05-058
• Study Type: observational
• Target: 722
• Locations: 2 countries
• Sites: 5

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.

Conditions

Breast Cancer; Breast Surgery; Breast Reconstruction; Breast Reduction; Breast Augmentation

Outcome Measures

Primary Outcomes (1)

• To develop and validate a new patient derived measure of satisfaction with breast surgery.

  conclusion of study

Secondary Outcomes (1)

• Determining variations in satisfaction related to patient characteristics and preoperative expectations.

  conclusion of study

Study Arms (2)

1

Postoperative Breast Surgery Patients

Behavioral: questionnaires

2

Preoperative Breast Surgery Patients

Behavioral: questionnaires

Interventions

questionnaires BEHAVIORAL

patients will fill out two questionnaires post surgery

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinics at the various sites

You may qualify if:

• 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
• Preoperative Group: Male and Female patients who are scheduled to undergo mastectomy, breast reconstruction, reduction, or augmentation or body contouring surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• McMaster University: collaborator
• University College, London: collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• University of British Columbia: collaborator
• Johns Hopkins University: collaborator
• University of Pittsburgh: collaborator

Study Sites (5)

John Hopkins Medical Center

Baltimore, Maryland, 21287, United States

Location

Dartmouth Medical Center

Lebanon, New Hampshire, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andrea Pusic, M.D., M.H.S.

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 31, 2008
• Study Start: June 1, 2005
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 14, 2013

Record last verified: 2013-11

Locations

US (4); CA (1)