Optimising Colorectal Cancer Screening Participation

September 28, 2021 updated by: University of Aarhus

Optimising Colorectal Cancer Screening Participation -A Randomised Controlled Trial of Invitation Procedures

The aim of this study is to demonstrate the effectiveness of three and four-staged invitation procedures compared to two-staged procedures by combining pre-notifications and reminders. The RCT will be nested into the Danish colorectal cancer screening programme in the Central Denmark Region including men and women aged 50-74 years. Participants will consecutively be randomized into four arms in a 1:1 ratio. Intervention arm 1 will receive a pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention), Intervention arm 2 will receive invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure), Intervention arm 3 will receive pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure). Finally, the forth arm will be a control group receiving usual care which invitation and one reminder 45 days after invitation (two-staged invitation procedure). Both pre-notifications and reminders are sent using digital mail.

The main out-come will be participation within 6 months after invitation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Randers, Denmark, 8930
        • Randers Regional Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Invited for colorectal cancer screening

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm I
pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention)
Procedure: Invitation procedure
Optimised invitation procedures in an organised colorectal cancer screening programme
Experimental: Intervention arm II
invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure)
Procedure: Invitation procedure
Optimised invitation procedures in an organised colorectal cancer screening programme
Experimental: Intervention arm III
pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure)
Procedure: Invitation procedure
Optimised invitation procedures in an organised colorectal cancer screening programme
Active Comparator: Control group
invitation and one reminder after 45 days (usual care)
Procedure: Invitation procedure
Optimised invitation procedures in an organised colorectal cancer screening programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of residents participating in colorectal cancer screening
Time Frame: Within six months after invitaiton
Number of residents participating in colorectal cancer screening in each of the four arms
Within six months after invitaiton

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Director: Berit Andersen, Professor, Randers Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2020

Primary Completion (Actual)

May 10, 2021

Study Completion (Actual)

May 10, 2021

Study Registration Dates

First Submitted

February 27, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • participationCRC2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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