Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners (OPTIDEC COLO)

Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners: A Randomized Controlled Cluster Trial

The goal of this randomized trial is to assess the effectiveness of a targeted telephone reminder strategy, implemented by the patient's general practitioner, in enhancing participation in colorectal cancer screening among individuals who are not up to date . The participants are patients between 50 to 74 years old as they are the target for colorectal cancer screening. The main questions are:

• What is the percentage of patients who completed the colorectal cancer screening test during the intervention year , within the patient population of general practitioners participating in the study and identified as non-up-to-date for their screening status ?
• Identifying potential factors influencing the effectiveness of the intervention based on various characteristics of the patient, the geographical area, the general practitioner, and the caller

Researchers will compare with other patients who are not up to date without the intervention of their general practionner with a telephone reminder.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Other: Intervention

• Study Type: Interventional
• Enrollment (Estimated): 10000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: José-philippe MORENO, MD; Phone Number: +33686663181; Email: jose_philippe.moreno@univ-fcomte.fr

Study Locations

• France
  • Franche-comté
    • Champlitte, Franche-comté, France
      • MSPU des 3 provinces
      • Principal Investigator: José-Philippe MORENO, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for general practionners :

• Practise in one of the four departments of the Franche-Comté region; ractise in a solo practice, group practice, multidisciplinary primary care centre , or community health centre;
• Are engaged in general medical practice.
• Have agreed to participate in the study.

Inclusion Criteria for patients :

• patients within the practice population of general practitioners selected to participate in the study;
• aged between 50 and 75 years inclusive;
• affiliated with the French general health insurance scheme or the agricultural social insurance scheme

Exclusion Criteria for general practionners:

• practise exclusively in a specialty other than general practice (e.g. osteopathy, allergology, vascular medicine).

Non inclusion Criteria for patients :

- Objection expressed by the patient to the change in the purpose of data processing for research purposes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm : phone-based outreach to promote colorectal cancer screening; In year n, the 50 selected general practitioners will receive from the national health insurance a list of patients who are not up to date with colorectal cancer screening. Each patient's screening status will be verified by the clinical research associate through a review of the medical records. A telephone call will be made by a member of the patient's primary care team.	Other: Intervention; A telephone call will be made by a member of the patient's primary care team (general practitioner, medical secretary, public health nurse, or care coordinator), with priority given to a call by the patient's general practitioner. The call should preferably be made to the patient's mobile phone. If the call is unsuccessful, a voicemail message will be left, and a second call will be attempted within the following seven days. The voicemail message will include the name of the patient's general practitioner, the purpose of the call regarding colorectal cancer screening, and notification that a further attempt will be made to reach the patient. If the telephone exchange is successful, an appointment at the healthcare facility will be offered to the patient, during which the screening test will be offered to the patient, during which the screening test will be handed over and explained by one of the healthcare professionals from the same facility.
No Intervention: Control arm; In year n, the 50 selected general practitioners will receive from the national health insurance a list of patients who are not up to date with colorectal cancer screening. Each patient's screening status will be verified by the clinical research associate through a review of the medical records. There will not be an intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients who completed the colorectal cancer screening in each arms	Patients who completed the colorectal cancer screening test during the intervention year (year n), within the patient population of general practitioners participating in the study, and who were identified from the national health insurance list as not up to date with screening - a status that was confirmed by reviewing their medical records. Completion of the screening will be confirmed by the presence of the test result in the patient's medical record within the General practionner's practice software, no later than three months after the end of the intervention. This mesure will be done in each arm.	6 months after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients whose colorectal cancer screening status was updated according to the National Health Insurance database	Patients whose colorectal cancer screening status changed between the list received from National Health in year n and the list received in year n+1. A change in status will be confirmed by the absence of the patient from the n+1 list, among those still registered within the general practitioner's patient panel.	1 year after enrollment
Number of patients who completed the colorectal cancer screening in the intervention arm according differents variables	Patients who completed the colorectal cancer screening (CRC) test during the intervention year , within the patient population of general practitioners participating in the study, and who were identified from the national health insurance list as not up to date with screening. This proportion will be analysed according to the following stratification variables: Patient-related variables: age, sex; Territorial variables: level of urbanisation, deprivation index, participation rate in CRC screening in 2023; General practionner-related variables: age, sex, solo vs group practice; Caller status: profession of the person who made the call	3 months after the end of enrollment
Number of participants per stage of the intervention process	In both study arms, identification of patients incorrectly included in the national health insurance list (i.e. patients already up to date with screening, those excluded from CRC screening, those under or awaiting colonoscopic follow-up, or currently undergoing treatment for colorectal cancer). For the intervention arm, classification of all patients according to the following outcomes: Patients contacted; Patients who refused screening; Patients who accepted to participate; Patients who attended the healthcare facility to collect the screening kit; Patients for whom the test result was received by the general practitioner	3 months after the end of enrollment
quantifying the time required to carry out the intervention	In the intervention arm, time spent on all stages of the intervention: Processing the Assurance Maladie list; Making telephone calls; Patient follow-up	3 months after the end of the enrollment

Collaborators and Investigators

• Sponsor: MSPU des 3 Provinces

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: June 29, 2025
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: prevention; colorectal cancer screening; general practionner
• Additional Relevant MeSH Terms: Investigative Techniques; Methods
• Other Study ID Numbers: 2025-A01370-49

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No