Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program (KITCOLO22)

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program; Other: Sending of a prior notification to the new entrants of the national program

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.

• Study Type: Interventional
• Enrollment (Actual): 64500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ardennes
    • Charleville-Mézières, Ardennes, France, 08000
      • Regional Cancer Screening Coordinating Centre, Ardennes site
  • Meurthe-et-Moselle
    • Nancy, Meurthe-et-Moselle, France, 54500
      • Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site
  • Moselle
    • Metz, Moselle, France, 57000
      • Regional Cancer Screening Coordinating Centre, Moselle Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Women and men aged 50 to 74 years old
• Living in the study area (Departments of Ardennes, Meurthe-et-Moselle, and Moselle, France)
• At moderate risk of colorectal cancer, i.e. eligible to the organised programme and receiving the first invitation of the screening round (not a reminder letter)

Exclusion Criteria:

• Outside the target age (less than 50 years old, or 75 years and more)
• Receiving the reminder letter
• At high or very high risk of colorectal cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Invitation letter to the screening program with the FIT test	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
Experimental: Intervention arm - sub study; Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test	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
No Intervention: Control arm; Invitation letter to visit its own GP who will deliver the FIT test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participation rates to the screening program	Comparison of the participation rate to the screening program between the intervention and the control arms	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral rates to coloscopy among those FIT positive	Comparison of the referral rates to coloscopy between the intervention and the control arms	2 years
Participation rates to the screening program	Comparison of the participation rates to the screening program between the individuals aged 50-52 of the Intervention1 and the Intervention sub-study arms	2 years

Collaborators and Investigators

• Sponsor: International Agency for Research on Cancer
• Investigators: Principal Investigator: Maurice TANGUY, MD, Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle site, Nancy, France; Principal Investigator: Myriam GUERBAZ SOMMI, MD, Regional Cancer Screening Coordinating Centre, Moselle site, Metz, France; Principal Investigator: Jean BOTO KEKY, MD, Regional Cancer Screening Coordinating Centre, Ardennes site, Charleville-Mézières, France

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): July 17, 2025
• Study Completion (Estimated): February 27, 2026

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: colorectal cancer; France; pilot project; randomised control trial; screening program
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: IEC/22-29

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
• product manufactured in and exported from the U.S.: No