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]

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 74
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Crcdc-Cvl
RECRUITING
Tours
Contact Information
Primary
Lydia GUITTET, MD,PhD
guittet-l@chu-caen.fr
+33(0)231065781
Time Frame
Start Date: 2023-09-14
Estimated Completion Date: 2026-11-14
Participants
Target number of participants: 64000
Treatments
Other: Control C
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.
Experimental: Intervention B1
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.
Experimental: Intervention B2
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.
Related Therapeutic Areas
Sponsors
Collaborators: Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire, Institut National de la Santé Et de la Recherche Médicale, France
Leads: University Hospital, Caen

This content was sourced from clinicaltrials.gov