Quality of Life Among Breast Reduction Patients

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00149370
First received: September 6, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted

September 6, 2005
September 6, 2005
January 2001
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No Changes Posted
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Quality of Life Among Breast Reduction Patients
A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes

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.

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)?

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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Breast Hypertrophy
Procedure: Breast reduction surgery
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
August 2003
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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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00149370
02-09-2005
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Hamilton Health Sciences Corporation
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Principal Investigator: Achilleas Thoma, MD MSc FRCSC McMaster Univeristy / St. Joseph's Healthcare
McMaster University
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP