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Trial Title:
Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening
NCT ID:
NCT05690958
Condition:
Barrett Esophagus
Barrett Adenocarcinoma
Esophageal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Barrett Esophagus
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Survey
Description:
Filling in a survey
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.
Criteria for eligibility:
Study pop:
A sample will be drawn from the Dutch population registry, the 'Basisregistratie
Personen' (BRP), using simple random sampling.
Sampling method:
Probability Sample
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.
Gender:
All
Gender based:
Yes
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
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Zip:
6525GA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
jasmijn sijben
Phone:
+31621193178
Email:
jasmijn.sijben@radboudumc.nl
Start date:
February 13, 2023
Completion date:
July 1, 2023
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
ZonMw: The Netherlands Organisation for Health Research and Development
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690958