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

Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests: A Discrete Choice-Based Conjoint Analysis

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.

Study Overview

• Status: Recruiting
• Conditions: Barrett Esophagus; Gastro Esophageal Reflux Disease
• Intervention / Treatment: Behavioral: Patient survey

Detailed Description

To achieve this goal, patient preferences for BE/EAC screening tests will be evaluated through a prospective multicenter discrete choice-based conjoint survey. Patients will choose between a series of hypothetical options and rank their priorities and what they value according to differences in benefit of detection (sensitivity), convenience (time, setting), screening related physical harms (procedural discomfort), and financial harms. By evaluating relative importance of test characteristics and patient prioritization the study will (1) define patient preferences and barriers for attributes of BE/EAC screening modalities to elicit the overall preferred test as well as differences in each attribute that informed that choice and (2) characterize differences in BE/EAC test preferences by patient sociodemographic characteristics (age, sex, race, ethnicity) and by the presence or absence of gastroesophageal reflux disease (GERD).

• Study Type: Observational
• Enrollment (Estimated): 556

Contacts and Locations

• Study Contact: Name: Alexa DeBord, MS; Phone Number: 303-724-0432; Email: alexa.debord@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Alexa DeBord, MS; Phone Number: 303-724-0432; Email: alexa.debord@cuanschutz.edu
      • Principal Investigator: Sachin Wani, MD
      • Sub-Investigator: Sridevi Pokala, MD
      • Sub-Investigator: Mohammad Bilal, MD
      • Sub-Investigator: Mark Earnest, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: University of California, Los Angeles; University of Michigan; University of Texas Southwestern Medical Center; Exact Sciences Corporation; American Society for Gastrointestinal Endoscopy; VA Medical Center-West Los Angeles
• Investigators: Principal Investigator: Sachin Wani, MD, University of Colorado - Anschutz Medical Campus; Principal Investigator: Jennifer Kolb, MD, MS, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Estimated): November 18, 2024

Study Record Updates

• Last Update Posted (Estimated): November 18, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: GERD; Barrett's Esophagus; Gastroesophageal Reflux Disease; Barrett's Esophagus Screening; BE
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Precancerous Conditions; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Neoplasms; Gastroesophageal Reflux; Barrett Esophagus
• Other Study ID Numbers: 23-1758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in original publications after deidentification (text, tables, figures, appendixes).
• IPD Sharing Time Frame: 9 months to 36 months following article publication.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No