Quality of Life in Barrett's Esophagus and Gastro-Esophageal Reflux Disease

Terminated

• Conditions: Barrett's Esophagus; Gastroesophageal Reflux Disease

• Registration Number: NCT01572974
• Lead Sponsor: Midwest Biomedical Research Foundation

Brief Summary

To Compare the overall quality of life of patients with no Barrett's esophagus , non-dysplastic Barrett's Esophagus (NDBE), Barrett's esophagus with low grade dysplasia (LGD), and Barrett's esophagus with high grade dysplasia (HGD). We also Compare the overall quality of life of Barrett's esophagus patients with severe gastroesophageal reflux disease (GERD) symptoms to those with no GERD symptoms

Detailed Description

The presence of GERD symptoms is associated with a significant decrease in quality of life.While a diagnosis of Barrett's esophagus is also associated with a decrease in quality of life, these studies evaluated Barrett's esophagus patients with GERD symptoms.It is unclear whether decrements in quality of life from cancer risk in patients with Barrett's esophagus are due to actual cancer risk or a patient's false perception.Here we Compare the overall quality of life of patients with no Barrett's esophagus , non-dysplastic Barrett's Esophagus (NDBE), Barrett's esophagus with low grade dysplasia (LGD), and Barrett's esophagus with high grade dysplasia (HGD). The Investigators will also Compare the overall quality of life of Barrett's esophagus patients with severe gastroesophageal reflux disease (GERD) symptoms to those with no GERD symptoms. Finally the investigators will compare the overall quality of life of patients with a perceived low risk of esophageal cancer to those with a perceived high risk of esophageal cancer

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-04
• Study First Posted: 2012-04-06
• Primary Completion: 2016-09
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Age 18 or above

At least one of the following:

Previous diagnosis of Barrett's esophagus Presence of GERD symptoms per patient report

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method	1 year	questionnaire

Secondary Outcome Measures

Name	Time	Method
SF-36 physical function (PF) subscale	12 months	questionnaire
SF-36 role limitations-physical (RP) subscale	12 months	questionnaire
SF-36 general health (GH) subscale	12 months	questionnaire

Trial Locations

Locations (1)

Kansas City VA Medical Center; 🇺🇸 Kansas City, Missouri, United States