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

Gastroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01572974
• Other study ID #: PS0056
• Status: Terminated
• Phase: N/A
• First received: April 4, 2012
• Last updated: January 16, 2018
• Start date: January 2010
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Midwest Biomedical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: December 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
United States	Kansas City VA Medical Center	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Midwest Biomedical Research Foundation	Kansas City Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. doi: 10.1016/j.cgh.2009.02.024. Epub 2009 Mar 10. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health State Utility as measured by the Time Trade-off (TTO) method/Standard Gamble (SG) method	questionnaire	1 year
Secondary	SF-36 physical function (PF) subscale	questionnaire	12 months
Secondary	SF-36 role limitations-physical (RP) subscale	questionnaire	12 months
Secondary	SF-36 general health (GH) subscale	questionnaire	12 months