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]

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).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: CRC screening invitation not including the screening test.; Other: Mailing of FIT with invitation; Other: Information letter before invitation

• Study Type: Interventional
• Enrollment (Estimated): 64000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lydia GUITTET, MD,PhD; Phone Number: +33(0)231065781; Email: guittet-l@chu-caen.fr

Study Locations

• France
  • Tours, France, 37000
    • Recruiting
    • Crcdc-Cvl
    • Contact: Julie BOYARD, ScD; Email: j.boyard@depistage-cancer.fr
    • Principal Investigator: Julie BOYARD, ScD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Centre Val de Loire

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2023
• Primary Completion (Estimated): March 14, 2025
• Study Completion (Estimated): November 14, 2026

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: September 4, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Screening; Participation
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2022-A01914-39

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No