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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT06032338
• Lead Sponsor: University Hospital, Caen

Brief 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-20
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-13
• Study Start: 2023-09-14
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-22
• Primary Completion: 2025-03-14
• Study Completion: 2026-11-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64000

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Performance of colonoscopy in FIT positive patients	6 months after the positive FIT	Rate of Colonoscopy within 6 months after positive FIT among invitees with a positive FIT
Participation to CRC screening program	16 months after the invitation	Rate of FIT sent to laboratory for analysis within 16 of months of invitation among invitees.

Secondary Outcome Measures

Name	Time	Method
Colonoscopy findings	12 months after the positive test	Rate of colorectal cancer or advanced neaplasia in invitees with a positive FIT
Time to screening participation	24 months after invitation	Time to screening participation within 24 months of invitation among invitees
Participation to CRC screening program at 24 months	24 months after invitation	Rate of FIT sent to laboratory for analysis within 24 of months of invitation among invitees.
Colonoscopy in FIT positive patients, 12 months after the positive test	12 months after the positive test	Rate of Colonoscopy within 12 months after positive FIT among invitees with a positive FIT
Time to colonoscopy (in FIT positive patients)	12 months after the positive test	Time from FIT to colonoscopy within 12 months of positive FIT among invitees with a positive FIT
Participation to CRC screening program in first invitees (50-51 yrs-old)	16 months after invitation	Rate of FIT sent to laboratory for analysis within 16 of months of invitation among first invitees (50-51 yrs-old)
Cost-effectiveness analysis	24 months	Costs of CSC-PBOSP from invitation to colonoscopy when necessary

Trial Locations

Locations (1)

Crcdc-Cvl; 🇫🇷 Tours, France