Back to resultsOptimising Colorectal Cancer Screening Participation
Primary Purpose
Colorectal Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Invitation procedure
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Neoplasms focused on measuring mass screening
Eligibility Criteria
Inclusion Criteria:
- Invited for colorectal cancer screening
Exclusion Criteria:
-
Sites / Locations
- Randers Regional Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Intervention arm I
Intervention arm II
Intervention arm III
Control group
Arm Description
pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention)
invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure)
pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure)
invitation and one reminder after 45 days (usual care)
Outcomes
Primary Outcome Measures
Number of residents participating in colorectal cancer screening
Number of residents participating in colorectal cancer screening in each of the four arms
Secondary Outcome Measures
Full Information
NCT ID
NCT04292366
First Posted
February 27, 2020
Last Updated
September 28, 2021
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT04292366
Brief Title
Optimising Colorectal Cancer Screening Participation
Official Title
Optimising Colorectal Cancer Screening Participation -A Randomised Controlled Trial of Invitation Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
mass screening
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm I
Arm Type
Experimental
Arm Description
pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention)
Arm Title
Intervention arm II
Arm Type
Experimental
Arm Description
invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure)
Arm Title
Intervention arm III
Arm Type
Experimental
Arm Description
pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
invitation and one reminder after 45 days (usual care)
Intervention Type
Procedure
Intervention Name(s)
Invitation procedure
Intervention Description
Optimised invitation procedures in an organised colorectal cancer screening programme
Primary Outcome Measure Information:
Title
Number of residents participating in colorectal cancer screening
Description
Number of residents participating in colorectal cancer screening in each of the four arms
Time Frame
Within six months after invitaiton
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Invited for colorectal cancer screening
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berit Andersen, Professor
Organizational Affiliation
Randers Regional Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Randers Regional Hospital
City
Randers
ZIP/Postal Code
8930
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36057390
Citation
Larsen MB, Hedelund M, Flander L, Andersen B. The impact of pre-notifications and reminders on participation in colorectal cancer screening - A randomised controlled trial. Prev Med. 2022 Nov;164:107229. doi: 10.1016/j.ypmed.2022.107229. Epub 2022 Aug 31.
Results Reference
derived
Learn more about this trial
Optimising Colorectal Cancer Screening Participation
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