NCT00149370

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2001

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2001

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2005

Completed
Last Updated

September 8, 2005

Status Verified

August 1, 2005

First QC Date

September 6, 2005

Last Update Submit

September 6, 2005

Conditions

Breast Hypertrophy

Keywords

breast hypertrophybreast reduction surgeryhealth-related quality of lifeHealth Utilities IndexHUIprospectiveSF-36quality-adjusted life yearsQALY

Interventions

Breast reduction surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unable or unwilling to complete the quality of life questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare / McMaster University

Hamilton, Ontario, L8N 4A6, Canada

Location

Related 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. doi: 10.1186/1477-7525-3-44.

    PMID: 16042775RESULT

MeSH Terms

Conditions

Gigantomastia

Study Officials

  • Achilleas Thoma, MD MSc FRCSC

    McMaster Univeristy / St. Joseph's Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 8, 2005

Study Start

January 1, 2001

Study Completion

August 1, 2003

Last Updated

September 8, 2005

Record last verified: 2005-08

Locations

CA(1)