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| Name | Class |
|---|---|
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| Centre Regional de Coordination des Depistages des Cancer - Pays de la Loire | OTHER |
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The effect of mailing FIT with the invitation on participation and colonoscopy rates will be evaluated in a randomized controlled trial conducted in the Centre-Val de Loire (CVL) region, involving 64,000 people from the population eligible for colorectal cancer population-based organised screening program (CRC-PBOSP).
In the "C" control group, invitations, test delivery and reminders will be carried out in accordance with the CRC-PBOSP rules at the time of the study.
Intervention group "B" will evaluate two experimental modes of invitation with direct home mailing of the test:
Ancillary studies will focus 1/ on acceptability of this intervention (qualitative study on a few general practitioners, gastroenterologists and invitees), 2/ on social and geographical inequalities of participation on a subsample of individuals included in EXPEDIT study using ecological indices (EDI, SCALE).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control "C" | Other | Usual care : Screening test (Fecal immunochemical test - FIT) delivery and reminders will be carried out in accordance with the Colorectal cancer population-based organised screening program (CRC-PBOSP) specifications at the time of the study. This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds. |
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| Intervention "B1" | Experimental | FIT mailed at home within the CRC screening invitation without prior information letter. This arm is suitable for both the first screening round in 50-51 years old population, and for the subsequent screening rounds. |
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| Intervention "B2" | Experimental | FIT mailed at home within the CRC screening invitation with prior information letter. This arm is suitable for the first screening round in 50-51 years old population only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRC screening invitation not including the screening test. | Other | The invitation to CRC-PBOSP will only contain informations on how to get the screening test. |
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| Measure | Description | Time Frame |
|---|---|---|
| Participation to CRC screening program | Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees. | 16 months after the invitation |
| Performance of colonoscopy in FIT positive patients | Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT | 6 months after the positive FIT |
| Measure | Description | Time Frame |
|---|---|---|
| Participation to CRC screening program at 24 months | Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees. | 24 months after invitation |
| Time to screening participation |
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Inclusion Criteria:
Exclusion Criteria:
Subjects refusing data transmission to research team will be excluded from statistical analyses.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crcdc-Cvl | Tours | 37000 | France |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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The number of study arms will differ according to age-group:
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| Mailing of FIT with invitation | Other | The invitation to CRC-PBOSP will contain the CRC screening test. |
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| Information letter before invitation | Other | An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit. |
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Time to screening participation within 24 months of invitation among invitees
| 24 months after invitation |
| Colonoscopy in FIT positive patients, 12 months after the positive test | Rate of Colonoscopy within 12 months after positive FIT among invitees with a positive FIT | 12 months after the positive test |
| Time to colonoscopy (in FIT positive patients) | Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT | 12 months after the positive test |
| Colonoscopy findings | Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT | 12 months after the positive test |
| Participation to CRC screening program in first invitees (50-51 yrs-old) | Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old) | 16 months after invitation |
| Cost-effectiveness analysis | Costs of CSC-PBOSP from invitation to colonoscopy when necessary | 24 months |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |