Public's Intended Uptake and Views on Organization of Eso... | NCT05690958

Studies
Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening

NCT05690958

Sponsor

Radboud University Medical Center

Status

Unknown status

Last Update Posted

Apr 5, 2023Actual

Enrollment

2,088Estimated

Phase

Not provided

Conditions

Barrett Esophagus
Barrett Adenocarcinoma
Esophageal Adenocarcinoma

Interventions

Survey

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2023Actual

Primary Completion Date

May 1, 2023Estimated

Completion Date

Jul 1, 2023Estimated

First Submitted Date

Jan 10, 2023

First Submission Date that Met QC Criteria

Jan 10, 2023

First Posted Date

Jan 19, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2023

Last Update Posted Date

Apr 5, 2023Actual

Name	Class
ZonMw: The Netherlands Organisation for Health Research and Development	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,088Estimated

Name	Type	Description	Arm Group Labels	Other Names
Survey	Other	Filling in a survey

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Views on the organization of EAC screening	Various items that are based on qualitative focus group results on the topic	Baseline

Other Outcomes

Measure	Description	Time Frame
Age		Baseline
Gender		Baseline
Education		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 45 to 75 years

Exclusion Criteria:

Previous diagnosis of EAC.
Unable to provide informed consent.
Unable to fill out the digital survey.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

All genders are included in the study. We provide a non-binairy answer option for gender.

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

A sample will be drawn from the Dutch population registry, the 'Basisregistratie Personen' (BRP), using simple random sampling.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jasmijn D Sijben, drs	Contact	+31629061198		jasmijn.sijben@radboudumc.nl

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radboudumc	Recruiting	Nijmegen	Gelderland	6525GA	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38619114	Derived	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.

ID	Term
D001471	Barrett Esophagus
C562730	Adenocarcinoma Of Esophagus

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms