Clinical trial NCT05589675: Evaluation of a New Invitation Procedure to the French Organized Colorectal Cancer Screening Program
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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
screening program
pilot project
randomised control trial
France
Lead sponsor: International Agency for Research on Cancer
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 64500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a three-arm study with a parallel study design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Participation rates to the screening program
timeFrame: 2 years
Secondary outcomes:
measure: Referral rates to coloscopy among those FIT positive
timeFrame: 2 years
measure: Participation rates to the screening program
timeFrame: 2 years
Other outcomes:
Locations:
city: Charleville-Mézières
country: France
facility: Regional Cancer Screening Coordinating Centre, Ardennes site
state: Ardennes
city: Nancy
country: France
facility: Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle Site
state: Meurthe-et-Moselle
city: Metz
country: France
facility: Regional Cancer Screening Coordinating Centre, Moselle Site
state: Moselle
Study officials:
affiliation: Regional Cancer Screening Coordinating Centre, Meurthe-et-Moselle site, Nancy, France
name: Maurice TANGUY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Cancer Screening Coordinating Centre, Moselle site, Metz, France
name: Myriam GUERBAZ SOMMI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Regional Cancer Screening Coordinating Centre, Ardennes site, Charleville-Mézières, France
name: Jean BOTO KEKY, MD
role: PRINCIPAL_INVESTIGATOR
References: