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
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
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 |
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 |
United States, Canada,
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 |
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