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

January 16, 2018 updated by: PRATEEK SHARMA, Midwest Biomedical Research Foundation

Quality of Life in Barrett's Esophagus and GERD:GERD Symptoms, Perception of Cancer Risk, and Actual Cancer Risk

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

Study Overview

Status

Terminated

Conditions

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 Type

Observational

Enrollment (Actual)

89

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Kansas City VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population is a Veteran population presenting to a VA Hospital with GERD symptom or Barrett's esophagus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No Barrett's esophagus
Subject without columnar lined esophagus
Nondysplastic BE
Subject with columnar lined esophagus and absence of dysplasia
Low grade dysplastic BE
subject with columnar lined esophagus and presence of low grade dysplasia
High grade dysplastic BE
subject with columnar lined esophagus and presence of high grade dysplasia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method
Time Frame: 1 year
questionnaire
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SF-36 physical function (PF) subscale
Time Frame: 12 months
questionnaire
12 months
SF-36 role limitations-physical (RP) subscale
Time Frame: 12 months
questionnaire
12 months
SF-36 general health (GH) subscale
Time Frame: 12 months
questionnaire
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Midwest Biomedical Research Foundation

Collaborators

Kansas City Veteran Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 4, 2012

First Posted (ESTIMATE)

April 6, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS0056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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