Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents (CHIMORAL)
Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Introduction :
Oral antineoplastic agents know a full development in particular targeted therapies. Their adverse events (AE) lately detected can lead to non compliance or treatment discontinuation which can be at the origin of disease progression. They can also lead to hospitalization or recourse to emergency department associating to cost for the society.
Hypothesis :
A coordinated intervention of cancer network in relation with primary healthcare professionals, would improve safety of care's patient treated with oral antineoplastic agent by preventing serious AEs through rapid detection.
Primary objective :
The primary objective is to estimate the effect of coordinated intervention of cancer network, in terms of number of early or unforeseen recourses to hospital for AE, within the first 6 months after oral neoplastic agent introduction.
Secondary objectives :
The secondary objective is to estimate the effect of coordinated intervention of cancer network, within the first 6 months after oral neoplastic agent introduction, in terms of number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, number of AE per detection grade, AE maximal grade, AE all grade, disease progression, the global survival (death for any causes and for AE), drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, quality of life, patient's satisfaction, medical economic evaluation
Primary outcome :
The main outcome is the number of early or unforeseen recourses to hospital for AE.
Secondary outcomes :
The secondary outcomes are all deaths and deaths from AE, number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, disease progression, drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, number of AE per detection grade, AE maximal grade, AE all grade, quality of life, patient's satisfaction, medical economic evaluationMethodology, design :
A comparative, controlled, not randomized, multicenter, prospective, "quasi-experimental" study, allows estimating evolution of patients according to the existence of a cancer network in their residence place.
Number of needed subjects: 440 patients.
Total duration of the study: 27 months. Inclusion Period: 21 months. length of participation period for one patient: 6 months. Number of participating centers: 21. Average number of inclusions a month by center: 4.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Paris, France, 75020
- Hopital Tenon
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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:
- patients affected by cancer (breast, colorectal, liver, lung, kidney, gastrointestinal stromal tumor, pancreas)
- treated by capecitabine, erlotinib, gefitinib, imatinib, lapatinib, sorafenib, sunitinib, vinorelbine, Evérolimus, Pazopanib, Etoposide, Topotécan
- 18 years old or more
Exclusion Criteria:
- refusal to participate
- lack proficiency in French ,
- having a Performance Status > 2,
- home based care,
- patient enrolled in clinical trials
- patient enrolled in therapeutic education program
- patient under administrative supervision or legal guardianship
- not affiliated with Patient Social Security or CMU (recipient or beneficiary)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Group " coordinated care"
Patient living in place covered by cancer network participating to the study is in the group "coordinated care"
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Group " usual care "
Patient living in place covered by cancer network non participating to the study or without cancer network is in the group "usual care"
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Number of early or unforeseen recourses to hospital for adverse event.
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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all deaths and deaths from AE
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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number of hospitalization for AE
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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number of consultation for AE
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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number of early or unforeseen recourses to hospital for grade 1 / 2 AE
Délai: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
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|
disease progression
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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drug dose-intensity taken by the patient during his treatment
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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number of recourses to the health care system
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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number of AE per detection grade, AE maximal grade, AE all grade
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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quality of life
Délai: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
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patient's satisfaction
Délai: within the first 6 monts after oral neoplastic agent introduction
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patient's satisfaction will be characterized with a questionnaire
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within the first 6 monts after oral neoplastic agent introduction
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medical economic evaluation
Délai: within the first 6 monts after oral neoplastic agent introduction
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Medical economic evaluation use The incremental cost-effectiveness ratio (ICER.
This is an equation used commonly in health economics to provide a practical approach to decision making regarding health interventions.
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within the first 6 monts after oral neoplastic agent introduction
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jean-¨Pierre Lotz, Professor, Assistance Publique - Hôpitaux de Paris
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 (Estimation)
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
Mots clés
Autres numéros d'identification d'étude
- NI 12019
- C1204 (Autre identifiant: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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