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

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ClinicalTrials.gov Identifier: NCT01572974
Recruitment Status : Terminated (Lack of recruitment)
First Posted : April 6, 2012
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
PRATEEK SHARMA, 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

Condition or disease
Barrett's Esophagus Gastroesophageal Reflux Disease

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
Actual Enrollment : 89 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method [ Time Frame: 1 year ]
    questionnaire


Secondary Outcome Measures :
  1. SF-36 physical function (PF) subscale [ Time Frame: 12 months ]
    questionnaire

  2. SF-36 role limitations-physical (RP) subscale [ Time Frame: 12 months ]
    questionnaire

  3. SF-36 general health (GH) subscale [ Time Frame: 12 months ]
    questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

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): NCT01572974


Locations
United States, Missouri
Kansas City VA Medical Center
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Prateek Sharma, MD Kansas City VA Medical Center

Publications:

Responsible Party: PRATEEK SHARMA, Principal Investigator, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT01572974     History of Changes
Other Study ID Numbers: PS0056
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

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

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