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Trial record 4 of 1524 for:    Recruiting, Not yet recruiting, Available Studies | "Colorectal Neoplasms"

Optimising Colorectal Cancer Screening Participation

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ClinicalTrials.gov Identifier: NCT04292366
Recruitment Status : Recruiting
First Posted : March 3, 2020
Last Update Posted : November 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: Invitation procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Optimising Colorectal Cancer Screening Participation -A Randomised Controlled Trial of Invitation Procedures
Actual Study Start Date : October 2, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention arm I
pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention)
Procedure: Invitation procedure
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)
Procedure: 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)
Procedure: 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)
Procedure: Invitation procedure
Optimised invitation procedures in an organised colorectal cancer screening programme




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Invited for colorectal cancer screening

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04292366


Contacts
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Contact: Mette Bach Larsen, PhD +4578420265 metbacla@rm.dk

Locations
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Denmark
Randers Regional Hospital Recruiting
Randers, Denmark, 8930
Contact: Mette Bach Larsen, PhD    +4578420265    metbacla@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Berit Andersen, Professor Randers Regional Hospital
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04292366    
Other Study ID Numbers: participationCRC2020
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: November 9, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
mass screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases