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

Caen University Hospital

Status: Enrolling

Conditions: Colorectal Cancer

Treatments: Other: CRC screening invitation not including the screening test.; Other: Mailing of FIT with invitation; Other: Information letter before invitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06032338

2022-A01914-39

Details and patient eligibility

About

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).

Enrollment: 64,000 estimated patients

Sex: All

Ages: 50 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64,000 participants in 3 patient groups

Control "C"

Other group

Description:

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.

Treatment:

Other: CRC screening invitation not including the screening test.

Intervention "B1"

Experimental group

Description:

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.

Treatment:

Other: Mailing of FIT with invitation

Intervention "B2"

Experimental group

Description:

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.

Treatment:

Other: Mailing of FIT with invitation

Other: Information letter before invitation