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

24. september 2026 opdateret af: 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 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

10000

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Franche-comté
      • Champlitte, Franche-comté, Frankrig
        • MSPU des 3 provinces
        • Ledende efterforsker:
          • José-Philippe MORENO, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

50 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria for general practitioners:

  • 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.

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 practitioners:

- 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Screening
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention Arm : phone-based outreach to promote colorectal cancer screening

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.

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.

Ingen indgriben: 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 be no intervention.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients who completed the colorectal cancer screening in each arms
Tidsramme: 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 practitioner's practice software, no later than three months after the end of the intervention. This measure will be applied in each arm

6 months after inclusion

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of patients whose colorectal cancer screening status was updated according to the National Health Insurance database
Tidsramme: 1 year after enrollment

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.

1 year after enrollment
Number of patients who completed the colorectal cancer screening in the intervention arm according differents variables
Tidsramme: 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 practitioner-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
Tidsramme: 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
Tidsramme: 3 months after the end of the enrollment

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

  • Processing the national health insurance list
  • Making telephone calls
  • Patient follow-up
3 months after the end of the enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. december 2027

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

29. juni 2025

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025-A01370-49

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