Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents

Study Overview
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Brief Summary
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The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events.

Detailed Description
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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.

Official Title
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Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents

Conditions
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Cancer

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group  coordinated care<br>Patient living in place covered by cancer network participating to the study is in the group coordinated care | |
| Group  usual care <br>Patient living in place covered by cancer network non participating to the study or without cancer network is in the group usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of early or unforeseen recourses to hospital for adverse event. |  | within the first 6 monts after oral neoplastic agent introduction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all deaths and deaths from AE |  | within the first 6 monts after oral neoplastic agent introduction | 
| number of hospitalization for AE |  | within the first 6 monts after oral neoplastic agent introduction | 
| number of consultation for AE |  | within the first 6 monts after oral neoplastic agent introduction | 
| number of early or unforeseen recourses to hospital for grade 1 / 2 AE |  | within the first 6 monts after oral neoplastic agent introduction | 
| disease progression |  | within the first 6 monts after oral neoplastic agent introduction | 
| drug dose-intensity taken by the patient during his treatment |  | within the first 6 monts after oral neoplastic agent introduction | 
| number of recourses to the health care system |  | within the first 6 monts after oral neoplastic agent introduction | 
| number of AE per detection grade, AE maximal grade, AE all grade |  | within the first 6 monts after oral neoplastic agent introduction | 
| quality of life |  | within the first 6 monts after oral neoplastic agent introduction | 
| patient's satisfaction | patient's satisfaction will be characterized with a questionnaire | within the first 6 monts after oral neoplastic agent introduction | 
| medical economic evaluation | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral antineoplastic agent, Cancer Networks, Continuity of care, Coordination of patient's care, Adverse Effects