Clinical trial NCT05690958: Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening
Official title: Dutch Population's Intended Uptake and Views on the Organization of Esophageal Cancer Screening: a Nationwide Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Barrett Esophagus
Barrett Adenocarcinoma
Esophageal Adenocarcinoma
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-01-19
Enrollment: 2088
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A sample will be drawn from the Dutch population registry, the 'Basisregistratie Personen' (BRP), using simple random sampling.

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.


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.

Primary outcomes:
measure: Intended uptake of EAC screening
timeFrame: Baseline
Secondary outcomes:
measure: Views on the organization of EAC screening
timeFrame: Baseline
Other outcomes:
measure: Age
timeFrame: Baseline
measure: Gender
timeFrame: Baseline
measure: Education
timeFrame: Baseline
measure: Current GERD symptoms
timeFrame: 7 days
measure: Marital status
timeFrame: Baseline
measure: Ethnicity
timeFrame: Baseline
measure: Previous upper endoscopy experience
timeFrame: Baseline
measure: Personal history of cancer
timeFrame: Baseline
measure: Knowing someone affected by esophageal cancer
timeFrame: Baseline
measure: General cancer worry
timeFrame: Baseline
measure: Perceived risk of EAC
timeFrame: Baseline
measure: General screening intent and beliefs about cancer screening
timeFrame: Baseline
measure: Anticipated discomfort during the screening test
timeFrame: Baseline
measure: Acceptability of screening test accuracy
timeFrame: Baseline
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: