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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
  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

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
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 McMaster University:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

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

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 25, 2014