Optimising Colorectal Cancer Screening Participation

NCT ID: NCT04292366

Last Updated: 2021-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2021-05-10

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.

Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention arm I

pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention)

Group Type EXPERIMENTAL

Invitation procedure

Intervention Type PROCEDURE

Optimised invitation procedures in an organised colorectal cancer screening programme

Intervention arm II

invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure)

Group Type EXPERIMENTAL

Invitation procedure

Intervention Type PROCEDURE

Optimised invitation procedures in an organised colorectal cancer screening programme

Intervention arm III

pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure)

Group Type EXPERIMENTAL

Invitation procedure

Intervention Type PROCEDURE

Optimised invitation procedures in an organised colorectal cancer screening programme

Control group

invitation and one reminder after 45 days (usual care)

Group Type ACTIVE_COMPARATOR

Invitation procedure

Intervention Type PROCEDURE

Optimised invitation procedures in an organised colorectal cancer screening programme

Interventions

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Invitation procedure

Optimised invitation procedures in an organised colorectal cancer screening programme

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Invited for colorectal cancer screening

Exclusion Criteria

\-
Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Berit Andersen, Professor

Role: STUDY_DIRECTOR

Randers Regional Hospital

Locations

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Randers Regional Hospital

Randers, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36057390 (View on PubMed)

Other Identifiers

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participationCRC2020

Identifier Type: -

Identifier Source: org_study_id

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