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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Paris, Frankrike, 75020
- Hôpital Tenon
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Number of early or unforeseen recourses to hospital for adverse event.
Tidsram: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
all deaths and deaths from AE
Tidsram: within the first 6 monts after oral neoplastic agent introduction
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within the first 6 monts after oral neoplastic agent introduction
|
|
|
number of hospitalization for AE
Tidsram: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
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|
number of consultation for AE
Tidsram: 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
Tidsram: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
disease progression
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
|
|
|
quality of life
Tidsram: within the first 6 monts after oral neoplastic agent introduction
|
within the first 6 monts after oral neoplastic agent introduction
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patient's satisfaction
Tidsram: 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
Tidsram: 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.
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within the first 6 monts after oral neoplastic agent introduction
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Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Jean-¨Pierre Lotz, Professor, Assistance Publique - Hôpitaux de Paris
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- NI 12019
- C1204 (Annan identifierare: ANSM)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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