Gastro Esophageal Reflux DiseaseNCT06693622
Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests
An observational study of Gastro Esophageal Reflux Disease and Barrett Esophagus, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastro Esophageal Reflux Disease, Barrett Esophagus
- What is being tested?
- Patient survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 556 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 1 Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- Unable to consent.
- Prior diagnosis of BE/EAC.
- Life limiting comorbidity/ disability.
- Active dementia/ cognitive impairment.
- Incarcerated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Alexa DeBord, MS, 303-724-0432, alexa.debord@cuanschutz.edu
Sachin Wani, MD
About this study
Official title: 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.
Read the 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).
- Being tested
- Patient survey
- Keywords
- Gastroesophageal Reflux Disease, Barrett's Esophagus, Barrett's Esophagus Screening, BE, GERD
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient surveyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Patient survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2024
- Study start1 Nov 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, University of California, Los Angeles, University of Michigan, Exact Sciences Corporation, VA Medical Center-West Los Angeles, University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Sachin Wani, MD, Principal investigator, University of Colorado, DenverJennifer Kolb, MD, MS, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06693622
- Sponsor's protocol ID
- 23-1758
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 18 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in original publications after deidentification (text, tables, figures, appendixes).
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preferences for Barrett's Esophagus and Esophageal Cancer Screening Tests: A Discrete Choice-Based Conjoint Analysis
- ClinicalTrials.gov ID
- NCT06693622
- Acronym / sponsor ID
- 23-1758
- Keywords
- Gastroesophageal Reflux Disease, Barrett's Esophagus, Barrett's Esophagus Screening, BE, GERD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Society for Gastrointestinal Endoscopy, University of California, Los Angeles, University of Michigan, Exact Sciences Corporation, VA Medical Center-West Los Angeles, University of Texas Southwestern Medical Center
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 18 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: Patient survey556 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- Unable to consent.
- Prior diagnosis of BE/EAC.
- Life limiting comorbidity/ disability.
- Active dementia/ cognitive impairment.
- Incarcerated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient surveyTo 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. | Behavioural | Patients |
Primary outcome
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.
1 secondary outcome
Characterization of differences in BE/EAC test preferences by patient sociodemographic characteristics and by patient presence or absence of GERD
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in original publications after deidentification (text, tables, figures, appendixes).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sachin Wani, MD principal investigator
University of Colorado, Denver
Jennifer Kolb, MD, MS principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastro Esophageal Reflux Disease and Barrett Esophagus, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexa DeBord, MS (303-724-0432, alexa.debord@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Define patient preferred BE/EAC screening test and barriers for attributes of BE/EAC screening tests (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2024.