Clinical trial NCT00149370: Quality of Life Among Breast Reduction Patients
Official title: A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Hypertrophy
Keywords: breast hypertrophy
breast reduction surgery
health-related quality of life
Health Utilities Index
HUI
prospective
SF-36
quality-adjusted life years
QALY
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2005-09-08
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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)?

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare / McMaster University
state: Ontario
Study officials:
affiliation: McMaster Univeristy / St. Joseph's Healthcare
name: Achilleas Thoma, MD MSc FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/1477-7525-3-44.