Quality of Life Among Breast Reduction Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-01-31

Study Completion Date

2003-08-31

Brief Summary

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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

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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)?

Conditions

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Breast Hypertrophy

Keywords

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breast hypertrophy breast reduction surgery health-related quality of life Health Utilities Index HUI prospective SF-36 quality-adjusted life years QALY

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Breast reduction surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Achilleas Thoma, MD MSc FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster Univeristy / St. Joseph's Healthcare

Locations

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St. Joseph's Healthcare / McMaster University

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT

PMID: 16042775 (View on PubMed)

Other Identifiers

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02-09-2005

Identifier Type: -

Identifier Source: org_study_id