Optimising Colorectal Cancer Screening Participation

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Procedure: Invitation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invited for colorectal cancer screening Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mass screening