Barrett EsophagusACCEPT-surveyNCT05690958
Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening
An observational study of Barrett Esophagus and Barrett Adenocarcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Research on novel methods to screen for esophageal adenocarcinoma (EAC) has expanded. Insight into individuals' drivers and barriers to attend screening is essential to tailor a potential new screening policy to their preferences. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus, Barrett Adenocarcinoma, Esophageal Adenocarcinoma
- What is being tested?
- Survey
- How many people
- 2,088 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Feb 2023to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A sample will be drawn from the Dutch population registry, the 'Basisregistratie Personen' (BRP), using simple random sampling.
Who may be able to join
- Aged 45 to 75 years
Who cannot join
- Previous diagnosis of EAC.
- Unable to provide informed consent.
- Unable to fill out the digital survey.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525GA
jasmijn sijben, +31621193178, jasmijn.sijben@radboudumc.nl
About this study
Official title: Dutch Population's Intended Uptake and Views on the Organization of Esophageal Cancer Screening: a Nationwide Survey
Rationale: Research on novel methods to screen for esophageal adenocarcinoma (EAC) has expanded. Insight into individuals' drivers and barriers to attend screening is essential to tailor a potential new screening policy to their preferences. Public preferences should also be considered on the organizational level to guarantee client-centered decision-making in the design of the screening process.
Objective: This study will examine Dutch individuals' intended uptake of EAC screening, including factors that predict uptake, and their views on its organization.
Read more
Study design: Cross-sectional population-based survey. Study population: Dutch individuals aged 45-75 years. The required sample size is 2088 and 8350 individuals will be invited based on an assumed participation rate of 25%.
Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.
Main study parameters/endpoints: The primary outcome of the study is the intended uptake of EAC screening (strong vs weak). Secondary study endpoints are the perceived need for consultation, perceived need for general education campaigns, acceptability of risk stratification scenarios, and acceptability of using health care resources for EAC screening.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study. Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 15 to 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.
- Being tested
- Survey
- Medical subject headings
- Barrett Esophagus, Adenocarcinoma Of Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Filling in a survey
What is being measured
The primary outcome is the main question the study is designed to answer.
Intended uptake of EAC screening
Participants will be informed about BE/EAC screening. Participants will also be informed about using upper endoscopy for this purpose and 1 out of 3 alternative hypothetical screening scenario's (transnasal endoscopy, ingestible cell-collection device, or breath analysis. Subsequently, participants will be asked if they intend to attend upper endoscopy and the alternative test if they were invited.
Measured: Baseline
Secondary outcomes (1)
Views on the organization of EAC screening
Various items that are based on qualitative focus group results on the topic
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start13 Feb 2023
- Primary completion1 May 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,088 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690958
- Sponsor's protocol ID
- 111597
- Acronym
- ACCEPT-survey
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sijben J, Rainey L, Maas F, Broeders MJM, Siersema PD, Peters Y. The Public's Intended Uptake of Hypothetical Esophageal Adenocarcinoma Screening Scenarios: A Nationwide Survey. Am J Gastroenterol. 2024 Sep 1;119(9):1802-1812. doi: 10.14309/ajg.0000000000002812. Epub 2024 Apr 15.
PubMed 38619114
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dutch Population's Intended Uptake and Views on the Organization of Esophageal Cancer Screening: a Nationwide Survey
- ClinicalTrials.gov ID
- NCT05690958
- Acronym / sponsor ID
- ACCEPT-survey / 111597
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,088 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 19 Jan 2023 (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.
Rationale: Research on novel methods to screen for esophageal adenocarcinoma (EAC) has expanded. Insight into individuals' drivers and barriers to attend screening is essential to tailor a potential new screening policy to their preferences. Public preferences should also be considered on the organizational level to guarantee client-centered decision-making in the design of the screening process.
Objective: This study will examine Dutch individuals' intended uptake of EAC screening, including factors that predict uptake, and their views on its organization.
Study design: Cross-sectional population-based survey. Study population: Dutch individuals aged 45-75 years. The required sample size is 2088 and 8350 individuals will be invited based on an assumed participation rate of 25%.
Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.
Main study parameters/endpoints: The primary outcome of the study is the intended uptake of EAC screening (strong vs weak). Secondary study endpoints are the perceived need for consultation, perceived need for general education campaigns, acceptability of risk stratification scenarios, and acceptability of using health care resources for EAC screening.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study. Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 15 to 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A sample will be drawn from the Dutch population registry, the 'Basisregistratie Personen' (BRP), using simple random sampling.
Key inclusion criteria (1 listed)
- Aged 45 to 75 years
Key exclusion criteria (3 listed)
- Previous diagnosis of EAC.
- Unable to provide informed consent.
- Unable to fill out the digital survey.
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 |
|---|---|---|
| SurveyFilling in a survey | Other | – |
Primary outcome
Intended uptake of EAC screening
Time frame: Baseline
Participants will be informed about BE/EAC screening. Participants will also be informed about using upper endoscopy for this purpose and 1 out of 3 alternative hypothetical screening scenario's (transnasal endoscopy, ingestible cell-collection device, or breath analysis. Subsequently, participants will be asked if they intend to attend upper endoscopy and the alternative test if they were invited.
1 secondary outcome
Views on the organization of EAC screening
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 38619114Sijben J, Rainey L, Maas F, Broeders MJM, Siersema PD, Peters Y. The Public's Intended Uptake of Hypothetical Esophageal Adenocarcinoma Screening Scenarios: A Nationwide Survey. Am J Gastroenterol. 2024 Sep 1;119(9):1802-1812. doi: 10.14309/ajg.0000000000002812. Epub 2024 Apr 15.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
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 Barrett Esophagus and Barrett Adenocarcinoma, run by Radboud University Medical Center at 1 site in Netherlands.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Apr 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jasmijn D Sijben, drs (+31629061198, jasmijn.sijben@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intended uptake of EAC screening (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05690958, which also lists 1 linked publication.
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 5 Apr 2023.