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

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]

Institut National de la Santé Et de la Recherche Médicale, France, Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire

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).

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.

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.

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.

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.

An information letter will be sent to future invitees a few weeks before the invitation, to announce the mailing of the CRC screening kit.

Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old)

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.