Colorectal NeoplasmsNCT04292366
Optimising Colorectal Cancer Screening Participation
A study testing Invitation procedure in people with Colorectal Neoplasms, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Invitation procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,000 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Oct 2020to 10 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invited for colorectal cancer screening
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimising Colorectal Cancer Screening Participation -A Randomised Controlled Trial of Invitation Procedures
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.
- Conditions
- Colorectal Neoplasms
- Being tested
- Invitation procedure
- Keywords
- mass screening
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation procedureProcedure or surgery
Optimised invitation procedures in an organised colorectal cancer screening programme
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm I | Experimental | pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention) Receives: Procedure: Invitation procedure |
| Intervention arm II | Experimental | invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure) Receives: Procedure: Invitation procedure |
| Intervention arm III | Experimental | pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure) Receives: Procedure: Invitation procedure |
| Control group | Active comparator | invitation and one reminder after 45 days (usual care) Receives: Procedure: Invitation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of residents participating in colorectal cancer screening
Number of residents participating in colorectal cancer screening in each of the four arms
Measured: Within six months after invitaiton
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start2 Oct 2020
- Primary completion10 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Berit Andersen, Professor, Study director, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292366
- Sponsor's protocol ID
- participationCRC2020
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36057390
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Colorectal Cancer Screening Participation -A Randomised Controlled Trial of Invitation Procedures
- ClinicalTrials.gov ID
- NCT04292366
- Acronym / sponsor ID
- participationCRC2020
- Conditions
- Colorectal Neoplasms
- Keywords
- mass screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60,000 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention arm I | Experimental | Procedure: Invitation procedurepre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention) |
| Intervention arm II | Experimental | Procedure: Invitation procedureinvitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure) |
| Intervention arm III | Experimental | Procedure: Invitation procedurepre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure) |
| Control group | Active comparator | Procedure: Invitation procedureinvitation and one reminder after 45 days (usual care) |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Invited for colorectal cancer screening
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invitation procedureOptimised invitation procedures in an organised colorectal cancer screening programme | Procedure or surgery | Control group, Intervention arm I, Intervention arm II, Intervention arm III |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Derived from this study: PubMed 36057390Larsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit Andersen, Professor study director
Randers Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation procedure in people with Colorectal Neoplasms, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of residents participating in colorectal cancer screening (time frame: Within six months after invitaiton). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292366, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.