Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorUniversity of Colorado, Denver
About this trial
This study plans to learn more about what patients think about screening for esophageal cancer (EAC) and Barrett's esophagus (BE); a pre-cancerous condition associated with esophageal cancer. The plan is to use this information to modify screening practices in the United States with the goal to decrease the number of people who die from esophageal cancer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision to sign and date the consent form.
Stated willingness to comply with all study procedures and be available for the duration of the study.
Individual has 3 or more established risk factors for BE (age > 50 years, chronic GERD, male, white race, smoking, obesity, family history of BE/EAC).
Disqualifiers
Unable to consent.
Prior diagnosis of BE/EAC.
Life limiting comorbidity/ disability.
Active dementia/ cognitive impairment.
Trial population
Patients with 3 or more established risk factors for BE who have at least one outpatient clinic visit at a participating site. Patients will be identified at primary care and family medicine clinics. Patients with prior diagnosis of BE/EAC will be excluded. Across the 5 sites, planned enrollment is 556.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patient survey
BehavioralTo assess patient preferences and barriers for attributes of BE/EAC screening modalities patients will complete a survey evaluating 5 domains: benefit of detection (sensitivity), convenience (time, setting), screening related physical harms (procedural discomfort), and financial harms. Prior to distribution, the survey will be refined and pretested among a sample of 5 patients.
Treatment groups
556 Participants
are divided into 1 treatment groupGroup A: Patients1 intervention
Trial outcomes
Primary outcomes
1
Define patient preferred BE/EAC screening test and barriers for attributes of BE/EAC screening tests
A discrete choice-based conjoint analysis survey evaluating 5 domains: benefit of detection (sensitivity), convenience (time, setting), screening related physical harms (procedural discomfort), and financial harms will be used to determine the relative importance of BE/EAC screening test characteristics and patient priorities. Survey data will be reported in aggregate and factors and choices will be analyzed using the Fisher Exact and Mann-Whitney rank-sum tests. This approach will elicit the overall preferred test and differences in each test attribute that informed the patients choice.
Time frame
BaselineSecondary outcomes
1
Characterization of differences in BE/EAC test preferences by patient sociodemographic characteristics and by patient presence or absence of GERD
Using the discrete choice-based conjoint analysis survey analysis, a logistic regression model of patient-specific attributes (age, sex, race, ethnicity) and by presence or absence of GERD will be used to evaluate if disparities in patient demographics or heath history impact complex decision making.
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
American Society for Gastrointestinal Endoscopy
Collaborator
University of California, Los Angeles
Collaborator
University of Michigan
Collaborator
Exact Sciences Corporation
Collaborator
VA Medical Center-West Los Angeles
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Source ClinicalTrials.gov