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

Barrett Esophagus Clinical Trial

— ACCEPT-survey  

Official title:

Dutch Population's Intended Uptake and Views on the Organization of Esophageal Cancer Screening: a Nationwide Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690958
• Other study ID #: 111597
• Status: Recruiting
• Start date: February 13, 2023
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2023
• Source: Radboud University Medical Center
• Contact: Jasmijn D Sijben, drs
• Phone: +31629061198
• Email: jasmijn.sijben[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2088
• Est. completion date: July 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Barrett Adenocarcinoma
• Barrett Esophagus
• Esophageal Adenocarcinoma
• Esophageal Neoplasms

Intervention

Other:
• Survey
Filling in a survey

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age		Baseline
Other	Gender		Baseline
Other	Education		Baseline
Other	Current GERD symptoms	Reflux Disease Questionnaire (RDQ)	7 days
Other	Marital status		Baseline
Other	Ethnicity		Baseline
Other	Previous upper endoscopy experience		Baseline
Other	Personal history of cancer		Baseline
Other	Knowing someone affected by esophageal cancer		Baseline
Other	General cancer worry	Lerman's cancer worry scale (CWS)	Baseline
Other	Perceived risk of EAC	Item adapted from HINTS survey	Baseline
Other	General screening intent and beliefs about cancer screening	Item adapted from screening module of awareness and beliefs about cancer (ABC) measure	Baseline
Other	Anticipated discomfort during the screening test	7-point Likert scale	Baseline
Other	Acceptability of screening test accuracy	7-point Likert scale	Baseline
Primary	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	Views on the organization of EAC screening	Various items that are based on qualitative focus group results on the topic	Baseline