ACCEPT-survey: Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening

Sponsor
Radboud University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05690958
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
2,088
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Survey

Study Design

Study Type:
Observational
Anticipated Enrollment :
2088 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Dutch Population's Intended Uptake and Views on the Organization of Esophageal Cancer Screening: a Nationwide Survey
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Views on the organization of EAC screening [Baseline]

    Various items that are based on qualitative focus group results on the topic

Other Outcome Measures

  1. Age [Baseline]

  2. Gender [Baseline]

  3. Education [Baseline]

  4. Current GERD symptoms [7 days]

    Reflux Disease Questionnaire (RDQ)

  5. Marital status [Baseline]

  6. Ethnicity [Baseline]

  7. Previous upper endoscopy experience [Baseline]

  8. Personal history of cancer [Baseline]

  9. Knowing someone affected by esophageal cancer [Baseline]

  10. General cancer worry [Baseline]

    Lerman's cancer worry scale (CWS)

  11. Perceived risk of EAC [Baseline]

    Item adapted from HINTS survey

  12. General screening intent and beliefs about cancer screening [Baseline]

    Item adapted from screening module of awareness and beliefs about cancer (ABC) measure

  13. Anticipated discomfort during the screening test [Baseline]

    7-point Likert scale

  14. Acceptability of screening test accuracy [Baseline]

    7-point Likert scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Radboud University Medical Center
  • ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Radboud University Medical Center
ClinicalTrials.gov Identifier:
NCT05690958
Other Study ID Numbers:
  • 111597
First Posted:
Jan 19, 2023
Last Update Posted:
Jan 19, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 19, 2023