Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery
This study is currently recruiting participants.
Verified March 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
McMaster University
University College, London
Dartmouth-Hitchcock Medical Center
University of British Columbia
Johns Hopkins University
University of Pittsburgh
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00605670
First received: January 11, 2008
Last updated: March 18, 2013
Last verified: March 2013
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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: | Observational Model: Cohort Time Perspective: 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:
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 ]
| Estimated Enrollment: | 610 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (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: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Clinics at the various sites
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605670
Contacts
| Contact: Andrea Pusic, MD | 212-639-5085 | |
| Contact: Peter Cordeiro, MD | 212-639-2521 |
Locations
| United States, Maryland | |
| John Hopkins Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Michele SHERMAK | |
| United States, New Hampshire | |
| Dartmouth Medical Center | Recruiting |
| Lebanon, New Hampshire, United States | |
| Contact: Carolyn Kerrigan, MD | |
| Principal Investigator: Carolyn Kerrigan, MD | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Andrea Pusic, MD 212-639-5085 | |
| Contact: Peter Cordeiro, MD 212-639-2521 | |
| Principal Investigator: Andrea Pusic, MD | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburg, Pennsylvania, United States | |
| Contact: J Peter Rubin | |
| Canada, British Columbia | |
| University of British Columbia | Recruiting |
| Vancouver, British Columbia, Canada | |
| Contact: Nancy Van Laeken, MD | |
| Principal Investigator: Nancy Van Laeken, MD | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
McMaster University
University College, London
Dartmouth-Hitchcock Medical Center
University of British Columbia
Johns Hopkins University
University of Pittsburgh
Investigators
| Principal Investigator: | Andrea Pusic, M.D., M.H.S. | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00605670 History of Changes |
| Other Study ID Numbers: | 05-058 |
| Study First Received: | January 11, 2008 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013