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Quality of Life Among Breast Reduction Patients

This study has been completed.

Sponsored by: Hamilton Health Sciences
Information provided by: Hamilton Health Sciences
ClinicalTrials.gov Identifier: NCT00149370
  Purpose

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.


Condition Intervention
Breast Hypertrophy
Procedure: Breast reduction surgery

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:   A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes

Further study details as provided by Hamilton Health Sciences:

Estimated Enrollment:   52
Study Start Date:   January 2001
Estimated Study Completion Date:   August 2003

Detailed Description:

This study addresses the following questions of clinical and policy relevance: 1) Is the pre-surgery HRQL of these patients compromised and, if so, in which areas? 2) Do patients’ HRQL improve after surgery and, if so, when and in which areas and by how much? 3) Is there a relationship between BMI and pre-/post-surgery changes in HRQL (i.e., is the pre/post effect similar for both obese and non-obese patients)? and 4) Is there a relationship between tissue re-section weight and pre-/post-surgery changes in HRQL (i.e., is the pre/post HRQL effect similar for patients having small and large amounts of tissue resected)?

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Diagnosis of breast hypertrophy
  • Government approval for payment of reduction mammoplasty

Exclusion Criteria:

  • Unable or unwilling to complete the quality of life questionnaires
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00149370

Locations
Canada, Ontario
St. Joseph's Healthcare / McMaster University    
      Hamilton, Ontario, Canada, L8N 4A6

Sponsors and Collaborators
Hamilton Health Sciences

Investigators
Principal Investigator:     Achilleas Thoma, MD MSc FRCSC     McMaster Univeristy / St. Joseph's Healthcare    
  More Information


Publications of Results:

Study ID Numbers:   02-09-2005
First Received:   September 6, 2005
Last Updated:   September 6, 2005
ClinicalTrials.gov Identifier:   NCT00149370
Health Authority:   Canada: Ethics Review Committee

Keywords provided by Hamilton Health Sciences:
breast hypertrophy  
breast reduction surgery  
health-related quality of life  
Health Utilities Index  
HUI  
prospective
SF-36
quality-adjusted life years
QALY

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Hypertrophy
Quality of Life

ClinicalTrials.gov processed this record on October 14, 2008




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