- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292366
Optimising Colorectal Cancer Screening Participation
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Randers, Denmark, 8930
- Randers Regional Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Invited for colorectal cancer screening
Exclusion Criteria:
-
Study Plan
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)
|
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)
|
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)
|
Optimised invitation procedures in an organised colorectal cancer screening programme
|
Active Comparator: Control group
invitation and one reminder after 45 days (usual care)
|
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
Sponsor
Investigators
- Study Director: Berit Andersen, Professor, Randers Regional Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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