- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02515344
Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer (IDLN)
Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer: Randomised Study Measuring the Impact on Participation
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Background:
Participation rate for colorectal cancer screening in France is 39%. In a Cochrane review, patient participation rates to colorectal cancer screening varies from 30 to 60%. Policy makers usually consider that these participation rates should be higher, based on the premise that the impact of the screening mainly depends on patient participation. In France, patients at average risk of colorectal cancer are eligible to the Faecal Occult Blood Test for colorectal cancer screening if: 1) they are older than 50 and younger than 74; 2) they have no personal history of colorectal cancer (or history of adenoma bigger than 1 cm) and no family history of colorectal cancer.
Objective:
To demonstrate that providing to GPs a list of their patients who are not compliant to colorectal cancer screening will 1) enhance patient participation to screening, and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design : Randomised controlled study, 3 parallel arms.
Design:
Randomized controlled study. 3 parallel arms.
Setting:
Primary care setting in France.
Enrollment:
In this study, the intervention will focus on the GP. The statistical unit for the results analysis will be the GP. GPs allocated in the 3 groups of the study will be all GPs 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average) and 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).
Intervention:
GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive the corresponding information.
Randomization:
3 groups : (A) GPs will receive a list of the patients who are not compliant to colorectal cancer screening, (B) GPs will receive a document providing general information on colorectal cancer screening, (C) GPs will not receive any specific document (they continue regular practice).
Primary outcome measure: Patient participation to colorectal cancer screening Secondary Outcome Measures: number of cancers screened in (versus diagnosed outside) the screening procedure.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Nantes, France, 44093
- CHU de Nantes
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
La description
In this study, the statistical unit is the GP.
Inclusion Criteria:
GPs allocated in the 3 groups of the study will be all GPs
- 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average)
- 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).
Exclusion Criteria:
- GPs who have less than 100 patients in their patient list
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: A: nominative list
Providing a list of patients not compliant with CRC sreening General Practitioners allocated to the intervention group (A) will receive:
|
GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive this information.
|
|
Comparateur actif: B: general information
Providing general information about CRC screening General Practitioners allocated to group (B) will receive: - a document providing general information about colorectal cancer screening (but will not receive the nominative list of patients non compliant to colorectal cancer screening) |
|
|
Aucune intervention: C: usual practice
General Practitioners allocated to group (C) will not receive any information (as in usual practice)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Patient participation rate to colorectal cancer screening
Délai: 12 months after starting date of the study
|
12 months after starting date of the study
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Number of cancers screened in (versus diagnosed outside) the screening procedure.
Délai: 12 months after starting date of the study
|
12 months after starting date of the study
|
Collaborateurs et enquêteurs
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimé)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs par site
- Tumeurs
- Maladies intestinales
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies du système digestif
- Maladies gastro-intestinales
- Tumeurs intestinales
- Maladies rectales
- Maladies du côlon
- Comportement
- Adhésion et conformité au traitement
- Comportement de santé
- Acceptation des soins de santé par le patient
- Tumeurs colorectales
- L'observance du patient
Autres numéros d'identification d'étude
- RC12_0497
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