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NCT Number: NCT06693622

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

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.

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Key information

Conditions

Gastro Esophageal Reflux Disease Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Alexa DeBord, MS

CONTACT

[email protected]

303-724-0432

Mark Earnest, MD

SUB_INVESTIGATOR

Mohammad Bilal, MD

SUB_INVESTIGATOR

Sachin Wani, MD

PRINCIPAL_INVESTIGATOR

Sridevi Pokala, MD

SUB_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Define patient preferred BE/EAC screening test and barriers for attributes of BE/EAC screening tests

    Time frame: Baseline

    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.

Secondary outcomes

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

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexa DeBord, MS

CONTACT

[email protected]

303-724-0432

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Society for Gastrointestinal Endoscopy
  • Exact Sciences Corporation
  • University of California, Los Angeles
  • University of Michigan
  • University of Texas Southwestern Medical Center
  • VA Medical Center-West Los Angeles

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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