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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00605670
Other study ID # 05-058
Secondary ID
Status Completed
Phase N/A
First received January 11, 2008
Last updated November 13, 2013
Start date June 2005
Est. completion date November 2013

Study information

Verified date November 2013
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Behavioral:
questionnaires
patients will fill out two questionnaires post surgery
questionnaires
Patient will fill out questionnaire before and 3 to 6 months after treatment.

Locations

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

Sponsors (7)

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

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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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