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| Name | Class |
|---|---|
| Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire | OTHER |
| INSERM U1086 ANTICIPE - Université Caen Normandie | UNKNOWN |
| URPS Centre Val de Loire | UNKNOWN |
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To be effective, organized colorectal cancer screening requires good adherence to diagnostic colonoscopy in the event of a positive test. In France, the rate of diagnostic colonoscopy following a positive colorectal cancer screening test is less than 85%, and the median delay is close to 90 days. After receiving their positive result from the laboratory, individuals with no known follow-up are contacted only six months later by the Regional Cancer Screening Coordination Centers (CRCDC) responsible for following up with individuals who have tested positive. To optimize follow-up with colonoscopy, earlier contact and information about colonoscopy appear to be necessary. The contribution of the general practitioner identified on the test could be an additional lever.
The SUIVICOLO study aims to evaluate the effectiveness on the rate of colonoscopies performed at 6 months of two strategies for optimizing the follow-up of positive results in comparison with control group C (current procedures of the CRCDC Centre Val de Loire without early letter).
The two strategies evaluated will be:
These strategies will be compared to the current follow-up strategy in a three arm randomized controlled arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (usual care) | Active Comparator |
| |
| Early letter with information leaflet about colonoscopy | Experimental | B1 |
|
| Early letter endorsed by the GP with information leaflet about colonoscopy | Experimental | B2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care follow-up by CRCDC | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Colonoscopy rate at 6 months after a positive test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of general practitioners who agreed to participate in the project | At baseline | |
| Colonoscopy rates at 12 months after a positive test | 12 months | |
| Colonoscopy rates at 18 months after a positive test |
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Inclusion Criteria:
Aged between 50 and 75 at the time of the positive colorectal cancer screening test
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lydia GUITTET, MD,PhD | Contact | 231065781 | +33 | lydia.guittet@unicaen.fr |
| Arnaud ALVES, MD,PhD | Contact | 231065781 | +33 | alves-a@chu-caen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Lydia GUITTET, MD,PhD | Caen Normandy University - INSERM U1086 ANTICIPE - Caen University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crcdc-Cvl | Tours | France | 37000 | France |
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This is a regional study controlled randomised into 3 parallel groups, comparing 2 interventions 'B1' and "B2" versus a control 'C' (Figure 2), stratified according to whether or not a general practitioner accepted to be associated to letters.
Randomisation will be stratified according to whether the beneficiary indicated the name of a general practitioner on the document accompanying their screening test and, where applicable, whether the general practitioner agreed to be associated to the letter provided for in the study.
Allocation would be 1:2:2 for control, intervention B1 and intervention B2 groups in case an agreeing GP is identified for the subject, and 1:1 for control and intervention B1 in the other case.
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|
| Information leaflet about colonoscopy follow-up | Other | An information leaflet about colonoscopy follow-up will be sent in an early letter 7 days after positive test result, and though QR-codes in subsequent reminders. |
|
| Endorsement of CRCDC letters from the GP | Other | Explicit mention of their general practitioner in letters and reminders sent by the CRCDC to individuals who have tested positive for colorectal cancer, including the information leaflet about colonoscopy or a link to this document (QR code). |
|
| 18 months |
| Colonoscopy rates at 24 months after a positive test | 24 months |
| Number of reminders in each group by type of reminder | 24 months |
| Number of people with contraindications to colonoscopy | 24 months |
| Number of people with a CT colonography | 24 months |
| Time to perform colonoscopy | 24 months |
| Colorectal cancer at colonoscopy | 24 months |
| Advanced neoplasia at colonoscopy | 24 months |
| Number of people who refused colonoscopy | 24 months |
| Number of lost to follow-up | 24 months |