Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering

Study Overview
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Brief Summary
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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: Method B1: invitation with test sent to home without prior information letter Method B2: information letter followed by invitation with test sent home, designed to optimize participation by first-time subjects (aged 50-51) invited to the CRC-PBOSP for the first time. 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).

Official Title
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EXPérimentation d'Envoi Postal DIrect à Domicile du kiT de dépistage du Cancer Colorectal Sans Commande préalable [Trial of Direct Home Delivery of Colorectal Cancer Screening Kit Without Pre-ordering]

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: CRC screening invitation not including the screening test.
* Other: Mailing of FIT with invitation
* Other: Information letter before invitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 to 74 years old Resident of Centre Val de Loire French area Eligible for CRC screening invitation within the biennal CRC-PBOSP during the inclusion period Affiliated to the health insurance scheme Exclusion Criteria: CRC screening exclusion criteria notified to CRCDC-CVL in a previous screening round (family or personal history of CRC/adenoma, inflammatory bowel disease) Colonoscopy in the previous 5 years) Subjects refusing data transmission to research team will be excluded from statistical analyses.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The number of study arms will differ according to age-group: In 50 or 51 yrs age-group, individuals (n=5760 ) will be randomised in 3 groups: C, B1 and B2 (allocation ratio 2:1:1) In the age-group older than 51 yrs, individuals (n=58240) will be randomised in 2 groups: C, and B1 (allocation 1:1) In the main analysis including both age-groups, B1 and B2 arms would be pooled.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control C<br>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. | Other: CRC screening invitation not including the screening test.<br>* The invitation to CRC-PBOSP will only contain informations on how to get the screening test.<br>|
| Experimental: Intervention B1<br>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. | Other: Mailing of FIT with invitation<br>* The invitation to CRC-PBOSP will contain the CRC screening test.<br>|
| Experimental: Intervention B2<br>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. | Other: Mailing of FIT with invitation<br>* The invitation to CRC-PBOSP will contain the CRC screening test.<br>Other: Information letter before invitation<br>* An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Participation