Optimising Colorectal Cancer Screening Participation

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292366
• Other study ID #: participationCRC2020
• Status: Completed
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: May 10, 2021

Study information

• Verified date: February 2020
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60000
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

• Invited for colorectal cancer screening

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

Procedure:
• Invitation procedure
Optimised invitation procedures in an organised colorectal cancer screening programme

Locations

Country	Name	City	State
Denmark	Randers Regional Hospital	Randers

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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