Quality of Life Among Breast Reduction Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00149370
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 8, 2005
Information provided by:
McMaster University

Brief Summary:

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 or disease Intervention/treatment
Breast Hypertrophy Procedure: Breast reduction surgery

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)?

Study Type : Observational
Enrollment : 52 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes
Study Start Date : January 2001
Study Completion Date : August 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00149370

Canada, Ontario
St. Joseph's Healthcare / McMaster University
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Achilleas Thoma, MD MSc FRCSC McMaster Univeristy / St. Joseph's Healthcare

Publications of Results: Identifier: NCT00149370     History of Changes
Other Study ID Numbers: 02-09-2005
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 8, 2005
Last Verified: August 2005

Keywords provided by McMaster University:
breast hypertrophy
breast reduction surgery
health-related quality of life
Health Utilities Index
quality-adjusted life years

Additional relevant MeSH terms:
Pathological Conditions, Anatomical