Optimising Colorectal Cancer Screening Participation
1 other identifier
interventional
60,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 3, 2020
CompletedStudy Start
First participant enrolled
October 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2021
CompletedSeptember 29, 2021
February 1, 2020
7 months
February 27, 2020
September 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Intervention arm I
EXPERIMENTALpre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention)
Intervention arm II
EXPERIMENTALinvitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure)
Intervention arm III
EXPERIMENTALpre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure)
Control group
ACTIVE COMPARATORinvitation and one reminder after 45 days (usual care)
Interventions
Optimised invitation procedures in an organised colorectal cancer screening programme
Eligibility Criteria
You may qualify if:
- Invited for colorectal cancer screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Randers Regional Hospital
Randers, 8930, Denmark
Related Publications (1)
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.
PMID: 36057390DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Berit Andersen, Professor
Randers Regional Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 3, 2020
Study Start
October 2, 2020
Primary Completion
May 10, 2021
Study Completion
May 10, 2021
Last Updated
September 29, 2021
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share