Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests

NCT06693622 | Recruiting

• 1 other identifier: 23-1758
• Study Type: observational
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastro Esophageal Reflux Disease; Barrett Esophagus

Keywords

Gastroesophageal Reflux Disease; Barrett's Esophagus; Barrett's Esophagus Screening; BE; GERD

Outcome Measures

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.

  Baseline

Secondary Outcomes (1)

• Characterization of differences in BE/EAC test preferences by patient sociodemographic characteristics and by patient presence or absence of GERD

  Baseline

Study Arms (1)

Patients

556 eligible patients will be recruited across 5 participating sites to complete a discrete choice-based conjoint survey. The survey will be distributed to eligible patients via Sawtooth internet survey at the time of a clinic appointment or remotely via video chat.

Behavioral: Patient survey

Interventions

Patient survey BEHAVIORAL

To 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.

Patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).

You may not qualify if:

• Unable to consent.
• Prior diagnosis of BE/EAC.
• Life limiting comorbidity/ disability.
• Active dementia/ cognitive impairment.
• Incarcerated.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• 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

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux; Barrett Esophagus

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Precancerous Conditions; Neoplasms

Study Officials

• Sachin Wani, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Jennifer Kolb, MD, MS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexa DeBord, MS

CONTACT

303-724-0432; alexa.debord@cuanschutz.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: November 18, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 months to 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose. These data can only be used for individual participant data meta-analysis.

Locations

US (1)