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NCT Number: NCT07639554

Optimizing Participation In Colorectal Cancer Screening By Direct Invitation Of Non Responders By General Practitionners

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.

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Key information

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MSPU des 3 provinces

Champlitte, Franche-comté, France

Location contact

José-Philippe MORENO, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Other

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.

Primary outcomes

  1. Number of patients who completed the colorectal cancer screening in each arms

    Time frame: 6 months after inclusion

    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.

Secondary outcomes

  1. Percentage of patients whose colorectal cancer screening status was updated according to the National Health Insurance database

    Time frame: 1 year after enrollment

    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.

  2. Number of patients who completed the colorectal cancer screening in the intervention arm according differents variables

    Time frame: 3 months after the end of enrollment

    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. Number of participants per stage of the intervention process

    Time frame: 3 months after the end of enrollment

    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
  4. quantifying the time required to carry out the intervention

    Time frame: 3 months after the end of the enrollment

    In the intervention arm, time spent on all stages of the intervention:

    • Processing the Assurance Maladie list
    • Making telephone calls
    • Patient follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

José-philippe MORENO, MD

CONTACT

[email protected]

+33686663181

Sponsors and collaborators

Lead sponsor

MSPU des 3 Provinces

Other

Registry information

Official study title

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

Acronym: OPTIDEC COLO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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