NCT05589675

Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program

Evaluation of the Home Delivery of the Screening Kit, and Impact of a Prior Notification Among New Participants to the National Organized Colorectal Cancer Screening Program (Among New Participants Only)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64,500 (actual)
• Sponsor: International Agency for Research on Cancer · Academic / Other
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Accepted

Summary

This is a randomized controlled trial comparing the effect on participation rates to colorectal cancer screening between an intervention arm (invitation letter to the screening program including a FIT test with or without prior notification) and a control arm with the standard of care (invitation letter to visit the GP who will deliver the FIT test).

Detailed description

The participation to the national screening program for colorectal cancer in France is low. In order to improve the performances of its organized program, the National Cancer Institute is planning to modify the invitation procedure. This is a pilot project and if an improvement in the program performances is reported, the invitation procedure may be scaled up. Eligible individuals for colorectal cancer screening will be identified by the Regional Cancer Screening Coordinating Centre and randomized into the intervention or control arms. They will be followed for FIT test submission to the central laboratory (participation to screening). Those who did not send their test will receive reminder letters. Those who had a positive FIT test will be followed up for coloscopy referral, and result of the coloscopy. Comparison of the participation rates to screening program and to coloscopy among those with a positive FIT test will be compared between the two study arms.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
OTHER	Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program	The individuals eligible for the colorectal cancer screening program will receive at home an invitation letter to participate to the program along with a FIT test. The follow-up will be similar to the standard of care, i.e. reminder letters at 5 and 10 months if there is no participation, and reminders if no coloscopy after a positive FIT test
OTHER	Sending of a prior notification to the new entrants of the national program	Dispatch of a notification, one month prior the dispatch of the screening test along the invitation letter. This intervention is among the new entrants to the national program

Timeline

• Start date: 2023-04-01
• Primary completion: 2025-07-17
• Completion: 2026-02-27
• First posted: 2022-10-21
• Last updated: 2025-07-28

Locations

3 sites across 1 country: France