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

This study is currently recruiting participants.

Verified October 2012 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: October 25, 2012

Last verified: October 2012

History of Changes

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:

MedlinePlus related topics: Cancer Esophagus Disorders GERD

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	December 2013 (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:

Gerson LB, Ullah N, Hastie T, Triadafilopoulos G, Goldstein M. Patient-derived health state utilities for gastroesophageal reflux disease. Am J Gastroenterol. 2005 Mar;100(3):524-33.

Crockett SD, Lippmann QK, Dellon ES, Shaheen NJ. Health-related quality of life in patients with Barrett's esophagus: a systematic review. Clin Gastroenterol Hepatol. 2009 Jun;7(6):613-23. Epub 2009 Mar 10. Review.

Eloubeidi MA, Provenzale D. Health-related quality of life and severity of symptoms in patients with Barrett's esophagus and gastroesophageal reflux disease patients without Barrett's esophagus. Am J Gastroenterol. 2000 Aug;95(8):1881-7.

Shaheen NJ, Green B, Medapalli RK, Mitchell KL, Wei JT, Schmitz SM, West LM, Brown A, Noble M, Sultan S, Provenzale D. The perception of cancer risk in patients with prevalent Barrett's esophagus enrolled in an endoscopic surveillance program. Gastroenterology. 2005 Aug;129(2):429-36.

Kruijshaar ME, Siersema PD, Janssens AC, Kerkhof M, Steyerberg EW, Essink-Bot ML; CYBAR Study Group. Patients with Barrett's esophagus perceive their risk of developing esophageal adenocarcinoma as low. Gastrointest Endosc. 2007 Jan;65(1):26-30.

Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.

Kulig M, Leodolter A, Vieth M, Schulte E, Jaspersen D, Labenz J, Lind T, Meyer-Sabellek W, Malfertheiner P, Stolte M, Willich SN. Quality of life in relation to symptoms in patients with gastro-oesophageal reflux disease-- an analysis based on the ProGERD initiative. Aliment Pharmacol Ther. 2003 Oct 15;18(8):767-76.

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:	October 25, 2012
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 May 21, 2013

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