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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

64500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-02-27

Brief Summary

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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).

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Detailed Description

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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

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

This is a three-arm study with a parallel study design

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention arm

Invitation letter to the screening program with the FIT test

Group Type EXPERIMENTAL

Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program

Intervention Type OTHER

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 arm - sub study

Prior notification to the new entrants, followed by an invitation letter to the screening program with the FIT test

Group Type EXPERIMENTAL

Dispatch of the screening test along the invitation letter to the national colorectal cancer screening program

Intervention Type OTHER

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

Sending of a prior notification to the new entrants of the national program

Intervention Type OTHER

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

Control arm

Invitation letter to visit its own GP who will deliver the FIT test

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes