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

5 de junio de 2026 actualizado por: MSPU des 3 Provinces

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.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

10000

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Franche-comté
      • Champlitte, Franche-comté, Francia
        • MSPU des 3 provinces
        • Investigador principal:
          • José-Philippe MORENO, MD

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
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.
Sin intervención: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of patients who completed the colorectal cancer screening in each arms
Periodo de tiempo: 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.

6 months after inclusion

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of patients whose colorectal cancer screening status was updated according to the National Health Insurance database
Periodo de tiempo: 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.

1 year after enrollment
Number of patients who completed the colorectal cancer screening in the intervention arm according differents variables
Periodo de tiempo: 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 months after the end of enrollment
Number of participants per stage of the intervention process
Periodo de tiempo: 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
3 months after the end of enrollment
quantifying the time required to carry out the intervention
Periodo de tiempo: 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
3 months after the end of the enrollment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de diciembre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2027

Finalización del estudio (Estimado)

1 de marzo de 2028

Fechas de registro del estudio

Enviado por primera vez

29 de junio de 2025

Primero enviado que cumplió con los criterios de control de calidad

5 de junio de 2026

Publicado por primera vez (Actual)

10 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025-A01370-49

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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