Colorectal Cancer ScreeningOPTIDEC COLONCT07639554
Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners
A study testing Intervention in people with Colorectal Cancer Screening, run by MSPU des 3 Provinces at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2026to 1 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Practice in one of the four departments of the Franche-Comté region;
- Practice 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.
- 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.
Who cannot join
- Practice 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
MSPU des 3 provinces
Champlitte, Franche-comté
José-Philippe MORENO, MD
About this study
Official title: 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 and 74 years old, as they are the target population 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 not up to date with their screening?
- 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 these patients with other patients who are not up to date and did not receive the telephone reminder intervention from their general practitioner.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Intervention
- Keywords
- prevention, colorectal cancer screening, general practionner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
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 handed over and explained by one of the healthcare professionals from the same facility.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm : phone-based outreach to promote colorectal cancer screening | Experimental | In year n, the 50 selected general practitioners will receive a list of patients who are not up to date with colorectal cancer screening from the national health insurance. Each patient's screening status will be verified by the clinical research associate through a review of the medical records. A telephone call will then be made by a member of the patient's primary care team. Receives: Other: Intervention |
| Control arm | No intervention | 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 be no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 practitioner's practice software, no later than three months after the end of the intervention. This measure will be applied in each arm
Measured: 6 months after inclusion
Secondary outcomes (4)
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 the National Health Insurance in year n and the list received in year n+1. This 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.
Measured: 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 practitioner-related variables: age, sex, solo vs. group practice
- Caller status: profession of the person who made the call
Measured: 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
Measured: 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 national health insurance list
- Making telephone calls
- Patient follow-up
Measured: 3 months after the end of the enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MSPU des 3 Provinces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639554
- Sponsor's protocol ID
- 2025-A01370-49
- Acronym
- OPTIDEC COLO
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No