- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03563924
Allo - Cancer - Thrombosis (AlloTC)
Management of venous thromboembolism (VTE) in patients with cancer is complex and require the intervention of many specialized health professionals, in hospital but also at home and during follow-up.
The AlloTC project aims to integrate the management of VTE within the multidisciplinary care pathway of the patient with cancer, in order to improve the management of VTE in patients with cancer: optimize treatments and follow-up with appropriate anticoagulants, monitor the implementation of good clinical practice, promote patient involvement and adherence.
The objective of this monocentric study is to evaluate the efficiency of the integration of the therapeutic management of VTE into a specific management of patient with cancer and to set up a specialized "AlloTC" team that coordinates this course of care.
For that purpose, the management of VTE and outcome of patients with cancer and VTE will be compared between two periods : traditional management and management with the "AlloTC" team.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Diagnosis of cancer or haematological malignancies
- Venous thromboembolism diagnosis (symptomatic or not)
Exclusion Criteria:
- Life expectancy ≤ 3 months
- Inability to understand or sign consent
- Inability to read or understand the French language
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
---|---|
Historical cohort
Patients with venous thromboembolism and cancer who follow traditional management of venous thromboembolism
|
|
AlloTC cohort
Patients with venous thromboembolism and cancer who follow "AlloTC" specific management.
"AlloTC" specific care path way develop a personalized care plan (PPS) and ensure the transmission of data (to all the interlocutors: patients and caregivers) at each step of the patient care path.
|
Setting up a specific care path "AlloTC" for management of TVE in patients with cancer with a specific coordination nurse within the "AlloTC" multidisciplinary team as a privileged interlocutor for health professionals and patients with the aim of simplifying the care pathways and ensuring a hospital-city interface organized in collaboration with the attending physician, to develop and publicize tools available for patients and caregivers (information documents, patient monitoring protocols, etc.)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of patients with appropriate care of venous thromboembolism
Délai: at 6 months
|
Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines
|
at 6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Percentage of patients with appropriate care of venous thromboembolism
Délai: at inclusion
|
Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines
|
at inclusion
|
Percentage of patients with appropriate care of venous thromboembolism
Délai: at 3 months
|
Percentage of patients who received appropriate care of venous thromboembolism according to the latest International Good Clinical Practice (GCP) guidelines
|
at 3 months
|
Number of calls from health professionals to the AlloTC team
Délai: at 6 months
|
at 6 months
|
|
Number of patients lost to follow-up
Délai: at 3 months
|
at 3 months
|
|
Number of patients lost to follow-up
Délai: at 6 months
|
at 6 months
|
|
Number of patients evaluated at multidisciplinary meeting
Délai: at 3 months
|
at 3 months
|
|
Number of patients evaluated at multidisciplinary meeting
Délai: at 6 months
|
at 6 months
|
|
Number of patients referred to the coordinating nurse in Oncology service
Délai: at 6 months
|
Number of patients referred to the coordinating nurse in Oncology service to reassess the need for supportive care and involve health professionals (dietitian, social worker, psychologist)
|
at 6 months
|
Number of complications
Délai: at 3 months
|
Recurrence of venous thromboembolism and bleeding episodes.
|
at 3 months
|
Number of complications
Délai: at 6 months
|
Recurrence of venous thromboembolism and bleeding episodes.
|
at 6 months
|
Caregiver satisfaction survey concerning on the AlloTC team and care path
Délai: at inclusion
|
at inclusion
|
|
Caregiver satisfaction survey concerning on the AlloTC team and care path
Délai: at 3 months
|
at 3 months
|
|
Caregiver satisfaction survey concerning on the AlloTC team and care path
Délai: at 6 months
|
at 6 months
|
|
Number of patients under care for venous thromboembolism integrated into a personalized care plan as defined in the '' 2009-2013 Cancer Plan ''
Délai: at 3 months
|
at 3 months
|
|
Number of patients under care for venous thromboembolism integrated into a personalized care plan as defined in the '' 2009-2013 Cancer Plan ''
Délai: at 6 months
|
at 6 months
|
|
Number of patients accessing the venous thromboembolism information documents.
Délai: at 6 months
|
at 6 months
|
|
Percentage of patients who had at least 1 session of specialized therapeutic education
Délai: at 6 months
|
at 6 months
|
|
Assessment of the quality of life of the patient
Délai: at inclusion
|
The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30'
|
at inclusion
|
Assessment of the quality of life of the patient
Délai: at 3 months
|
The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30'
|
at 3 months
|
Assessment of the quality of life of the patient
Délai: at 6 months
|
The quality of life of each patient will be evaluate using the quality of life scale 'EORTC QLC-30'
|
at 6 months
|
Patient satisfaction survey concerning the AlloTC team and care path
Délai: at inclusion
|
at inclusion
|
|
Patient satisfaction survey concerning the AlloTC team and care path
Délai: at 3 months
|
at 3 months
|
|
Patient satisfaction survey concerning the AlloTC team and care path
Délai: at 6 months
|
at 6 months
|
|
Number of hospitalizations in the AlloTC cohort
Délai: at 3 months
|
at 3 months
|
|
Number of hospitalizations in the AlloTC cohort
Délai: at 6 months
|
at 6 months
|
|
Hospitalization duration in the AlloTC cohort
Délai: at 3 months
|
at 3 months
|
|
Hospitalization duration in the AlloTC cohort
Délai: at 6 months
|
at 6 months
|
Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
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
Autres numéros d'identification d'étude
- K171103J
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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