Clinical trial NCT06693622: Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests
Official title: Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests: A Discrete Choice-Based Conjoint Analysis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastro Esophageal Reflux Disease
Barrett Esophagus
Keywords: Gastroesophageal Reflux Disease
Barrett's Esophagus
Barrett's Esophagus Screening
BE
GERD
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Society for Gastrointestinal Endoscopy
name: University of California, Los Angeles
name: University of Michigan
name: Exact Sciences Corporation
name: VA Medical Center-West Los Angeles
name: University of Texas Southwestern Medical Center
First posted: 2024-11-18
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Define patient preferred BE/EAC screening test and barriers for attributes of BE/EAC screening tests
timeFrame: Baseline
Secondary outcomes:
measure: Characterization of differences in BE/EAC test preferences by patient sociodemographic characteristics and by patient presence or absence of GERD
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sachin Wani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Jennifer Kolb, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: