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Completed

NCT Number: NCT00605670

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

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.

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Key information

Conditions

Breast Cancer Breast Augmentation Breast Diseases Breast Neoplasms Breast Reconstruction Breast Reduction Breast Surgery Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaires

Behavioral

patients will fill out two questionnaires post surgery

Primary outcomes

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

    Time frame: conclusion of study

Secondary outcomes

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

    Time frame: conclusion of study

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Dartmouth-Hitchcock Medical Center
  • Johns Hopkins University
  • McMaster University
  • University College, London
  • University of British Columbia
  • University of Pittsburgh

Registry information

Official study title

Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument

Important dates

Study start
2005
Primary completion
2013
Study completion
2013
First posted
Jan 31, 2008
Registry last updated
Nov 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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