Quality of Life Among Breast Reduction Patients

Completed

• Conditions: Breast Hypertrophy

• Registration Number: NCT00149370
• Lead Sponsor: Hamilton Health Sciences Corporation

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.

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 Timeline

• Study Start: 2001-01
• Study Completion: 2003-08
• Status Verified: 2005-08
• Study First Submitted: 2005-09-06
• Study First Submitted QC: 2005-09-06
• Last Update Submitted: 2005-09-06
• Study First Posted: 2005-09-08
• Last Update Posted: 2005-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 52

Inclusion Criteria

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

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Exclusion Criteria

• Unable or unwilling to complete the quality of life questionnaires

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

St. Joseph's Healthcare / McMaster University; 🇨🇦 Hamilton, Ontario, Canada