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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01572974

Enrollment

Registered

2012-04-06

Start date

2010-01-31

Completion date

2017-12-31

Last updated

2018-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett's Esophagus, Gastroesophageal Reflux Disease

Keywords

Barrett's esophagus, Gastroesophageal reflux disease, Quality of life

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

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results