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
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Paris, Francie, 75020
- Hôpital Tenon
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
Group " coordinated care"
Patient living in place covered by cancer network participating to the study is in the group "coordinated care"
|
|
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"
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Number of early or unforeseen recourses to hospital for adverse event.
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
all deaths and deaths from AE
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of hospitalization for AE
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of consultation for AE
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of early or unforeseen recourses to hospital for grade 1 / 2 AE
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
disease progression
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
drug dose-intensity taken by the patient during his treatment
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of recourses to the health care system
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of AE per detection grade, AE maximal grade, AE all grade
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
quality of life
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
patient's satisfaction
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
patient's satisfaction will be characterized with a questionnaire
|
within the first 6 monts after oral neoplastic agent introduction
|
|
medical economic evaluation
Časové okno: within the first 6 monts after oral neoplastic agent introduction
|
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.
|
within the first 6 monts after oral neoplastic agent introduction
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Jean-¨Pierre Lotz, Professor, Assistance Publique - Hôpitaux de Paris
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- NI 12019
- C1204 (Jiný identifikátor: ANSM)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .