Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program (KITCOLO22)
Primary Purpose
Colorectal Cancer
Status
Enrolling by invitation
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program
Sending of a prior notification to the new entrants of the national program
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer focused on measuring colorectal cancer, screening program, pilot project, randomised control trial, France
Eligibility Criteria
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
Sites / Locations
- Regional Cancer Screening Coordinating Centre, Ardennes site
- Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site
- Regional Cancer Screening Coordinating Centre, Moselle Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Intervention arm
Intervention arm - sub study
Control arm
Arm Description
Invitation letter to the screening program with the FIT test
Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test
Invitation letter to visit its own GP who will deliver the FIT test
Outcomes
Primary Outcome Measures
Participation rates to the screening program
Comparison of the participation rate to the screening program between the intervention and the control arms
Secondary Outcome Measures
Referral rates to coloscopy among those FIT positive
Comparison of the referral rates to coloscopy between the intervention and the control arms
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
Full Information
NCT ID
NCT05589675
First Posted
October 18, 2022
Last Updated
September 28, 2023
Sponsor
International Agency for Research on Cancer
1. Study Identification
Unique Protocol Identification Number
NCT05589675
Brief Title
Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program
Acronym
KITCOLO22
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 17, 2025 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Agency for Research on Cancer
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
colorectal cancer, screening program, pilot project, randomised control trial, France
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a three-arm study with a parallel study design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Invitation letter to the screening program with the FIT test
Arm Title
Intervention arm - sub study
Arm Type
Experimental
Arm Description
Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Invitation letter to visit its own GP who will deliver the FIT test
Intervention Type
Other
Intervention Name(s)
Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Sending of a prior notification to the new entrants of the national program
Intervention Description
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
Primary Outcome Measure Information:
Title
Participation rates to the screening program
Description
Comparison of the participation rate to the screening program between the intervention and the control arms
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Referral rates to coloscopy among those FIT positive
Description
Comparison of the referral rates to coloscopy between the intervention and the control arms
Time Frame
2 years
Title
Participation rates to the screening program
Description
Comparison of the participation rates to the screening program between the individuals aged 50-52 of the Intervention1 and the Intervention sub-study arms
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice TANGUY, MD
Organizational Affiliation
Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle site, Nancy, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myriam GUERBAZ SOMMI, MD
Organizational Affiliation
Regional Cancer Screening Coordinating Centre, Moselle site, Metz, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean BOTO KEKY, MD
Organizational Affiliation
Regional Cancer Screening Coordinating Centre, Ardennes site, Charleville-Mézières, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Cancer Screening Coordinating Centre, Ardennes site
City
Charleville-Mézières
State/Province
Ardennes
ZIP/Postal Code
08000
Country
France
Facility Name
Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site
City
Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Facility Name
Regional Cancer Screening Coordinating Centre, Moselle Site
City
Metz
State/Province
Moselle
ZIP/Postal Code
57000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program
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