Quality of Life Among Breast Reduction Patients
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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 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 |
| Estimated Enrollment: | 52 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | August 2003 |
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 |
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| Canada, Ontario | |
| St. Joseph's Healthcare / McMaster University | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| 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 May 23, 2013