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

Recruiting

• Conditions: Barrett Esophagus; Barrett Adenocarcinoma; Esophageal Adenocarcinoma

• Registration Number: NCT05690958
• Lead Sponsor: Radboud University Medical Center

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 available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-19
• Study Start: 2023-02-13
• Last Update Submitted: 2023-04-03
• Last Update Posted: 2023-04-05
• Primary Completion: 2023-05-01
• Study Completion: 2023-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2088

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intended uptake of EAC screening	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.

Secondary Outcome Measures

Name	Time	Method
Views on the organization of EAC screening	Baseline	Various items that are based on qualitative focus group results on the topic

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands