Quality of Life Among Breast Reduction Patients

Breast Hypertrophy Clinical Trial

Official title:

A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00149370
• Other study ID #: 02-09-2005
• Status: Completed
• Phase: N/A
• First received: September 6, 2005
• Last updated: September 6, 2005
• Start date: January 2001
• Est. completion date: August 2003

Study information

• Verified date: August 2005
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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)?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Breast Hypertrophy
• Hypertrophy

Intervention

Procedure:
• Breast reduction surgery

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare / McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation