Colorectal Cancer Screening
Conditions
Keywords
Colonoscopy, Fecal immunochemical test
Brief summary
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: * Group B1: Sending an early letter signed by the CRCDC accompanied by information leaflet about colonoscopy * Group B2: Sending an early letter co-signed by the CRCDC and the general practitioner (identified or provided by the patient on the test identification form) accompanied by information leaflet about colonoscopy. These strategies will be compared to the current follow-up strategy in a three arm randomized controlled arm.
Interventions
OTHERUsual care follow-up by CRCDC
1. 6 months after positive test result: 1st reminder letter from the CRCDC if it has no information about a colonoscopy being performed 2. 12 months after positive test result: 2nd reminder letter from the CRCDC if it has no information about a colonoscopy being performed 3. 18 months after positive test result: 3rd reminder letter from the CRCDC if it has no information about a colonoscopy being performed
OTHERInformation leaflet about colonoscopy follow-up
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.
OTHEREndorsement of CRCDC letters from the GP
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).
Sponsors
University Hospital, Caen
Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire
INSERM U1086 ANTICIPE - Université Caen Normandie
URPS Centre Val de Loire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 50 and 75 at the time of the positive colorectal cancer screening test * Residing in one of the departments of the Centre Val de Loire region * Date on which the positive CRC screening test result was sent to the beneficiary recorded * Colorectal cancer screening test results sent to the beneficiary within 30 days of the test being read * Affiliated with a health insurance fund
Exclusion criteria
* Subjects who have notified their refusal to allow their data to be used for research purposes will be excluded from the analyses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colonoscopy rate at 6 months after a positive test | 6 months |
Secondary
| Measure | 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 | 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 |
Countries
France
Contacts
CONTACTLydia GUITTET, MD,PhD
CONTACTArnaud ALVES, MD,PhD
STUDY_DIRECTORLydia GUITTET, MD,PhD
Caen Normandy University - INSERM U1086 ANTICIPE - Caen University Hospital
Outcome results
None listed