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

This study is currently recruiting participants.
Verified March 2014 by Midwest Biomedical Research Foundation
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT01572974
First received: April 4, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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


Condition
Barrett's Esophagus
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality of Life in Barrett's Esophagus and GERD:GERD Symptoms, Perception of Cancer Risk, and Actual Cancer Risk

Resource links provided by NLM:


Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:
  • Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    questionnaire


Secondary Outcome Measures:
  • SF-36 physical function (PF) subscale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • SF-36 role limitations-physical (RP) subscale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire

  • SF-36 general health (GH) subscale [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    questionnaire


Estimated Enrollment: 384
Study Start Date: January 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572974

Contacts
Contact: April Higbee, RN, BSN 816-861-4700 april.higbee@va.gov

Locations
United States, Missouri
Kansas City VA Medical Center Recruiting
Kansas City, Missouri, United States, 64128
Contact: April Higbee, RN,BSN    816-861-4700 ext 57456    april.higbee@va.gov   
Sub-Investigator: Ajay Bansal, MD         
Sub-Investigator: Amit Rastogi, MD         
Principal Investigator: Prateek Sharma, MD         
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Prateek Sharma, MD Kansas City VA Medical Center
  More Information

Publications:

Responsible Party: PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT01572974     History of Changes
Other Study ID Numbers: PS0056
Study First Received: April 4, 2012
Last Updated: March 31, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Midwest Biomedical Research Foundation:
Barrett's esophagus
Gastroesophageal reflux disease
Quality of life

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on April 21, 2014