NCT00149370|Completed
Quality of Life Among Breast Reduction Patients
A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes
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A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes
Sponsor study identifier
observational
52
1 country
1
Study Start
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
August 2003
Date type not reportedThis date has not been verified as actual or estimated.
Despite the growing evidence showing that breast hypertrophy is associated with reduced Health-Related Quality of Life (HRQL) and that reduction mammoplasty has a significant positive impact on HRQL, there are unresolved issues that need to be addressed. These include our ability to measure quantitatively the change that occurs after reduction and the ongoing restriction or denials of third party payments based on body mass index (BMI). The primary purpose of this study is to assess and measure the HRQL experienced by breast reduction patients using four reliable and validated HRQL measures. Fifty-two consecutive patients with the diagnosis of breast hypertrophy were invited to participate in this prospective study. Participants completed the Health Utilities Index Mark 2 (HUI2) and Mark 3 (HUI3) and the Breast Reduction Assessment Value and Outcomes (BRAVO) instruments (the Short Form 36, the Multidimensional Body-Self Rating Questionnaire Appearance Assessment, and the Breast Related Symptom Questionnaire) at one week and one day pre-surgery and one, six, and 12 months post-surgery.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2003
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
August 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 6, 2005
Actual (reported)September 8, 2005
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St. Joseph's Healthcare / McMaster University
Hamilton, Ontario, L8N 4A6, Canada
Thoma A, Sprague S, Veltri K, Duku E, Furlong W. Methodology and measurement properties of health-related quality of life instruments: a prospective study of patients undergoing breast reduction surgery. Health Qual Life Outcomes. 2005 Jul 22;3:44. doi: 10.1186/1477-7525-3-44.
Achilleas Thoma, MD MSc FRCSC
McMaster Univeristy / St. Joseph's Healthcare
First Submitted
September 6, 2005
First Posted
September 8, 2005
Study Start
January 2001
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
August 2003
Date type not reportedComparison of Superomedial and Inferior Pedicle Techniques in Mammaplasty
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This date has not been verified as actual or estimated.
Last Updated
September 8, 2005
Record last verified: 2005-08
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Source: ClinicalTrials.gov.
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