Quality of Life Among Breast Reduction Patients
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|ClinicalTrials.gov Identifier: NCT00149370|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 8, 2005
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 or disease||Intervention/treatment|
|Breast Hypertrophy||Procedure: Breast reduction surgery|
|Study Type :||Observational|
|Estimated Enrollment :||52 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||A Prospective Study of Patients Undergoing Breast Reduction Surgery: Health-Related Quality of Life and Clinical Outcomes|
|Study Start Date :||January 2001|
|Estimated Study Completion Date :||August 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149370
|St. Joseph's Healthcare / McMaster University|
|Hamilton, Ontario, Canada, L8N 4A6|
|Principal Investigator:||Achilleas Thoma, MD MSc FRCSC||McMaster Univeristy / St. Joseph's Healthcare|