Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology

Study Overview
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Brief Summary
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The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI

Detailed Description
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This study aims to highlight the impact of Patient Therapeutic Education (TPE) in oncology. TPE is an integral part of the care pathway for patients with a chronic pathology such as diabetes, asthma, chronic obstructive pulmonary disease, cardiovascular diseases requiring anticoagulants, haemophilia, renal failure, HIV infection, autoimmune diseases etc.... front of therapeutic progress, many cancers are now taken for a chronic disease. In oncology, TPE starts to grow. Indeed, TPE makes the patient more autonomous, which could reduce the occurrence and / or aggravation of some toxicities, improve the quality of life, the effectiveness of treatment and optimize health costs. Therefore, it is important to develop programme of therapeutic education in oncology. The toxicity of ICI is unusual and sometimes lethal. This toxicity must be recognized and managed quickly to maintain a satisfactory dose-intensity. TPE finds its place by raising awareness among patient to the occurrence of these toxicities. This randomized TPE versus standard care study project will assess the contribution of education in the management of severe toxicities. The investigators believe that changes in patient behaviour will reduce the number of toxicities ≥3 in the TPE arm.

Official Title
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Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology

Conditions
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Melanoma, Therapeutic Patient Education, Immune Checkpoint Inhibitors, Advanced Non-small Cell Lung Cancer, Renal Cell Carcinoma, Head and Neck Cancer, Immune-related Adverse Event

Intervention / Treatment
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* Behavioral: Therapeutic education program
* Behavioral: Usual Information


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Melanoma, Non-Small Cell Bronchial Cancer, renal cell carcinoma, Ca carcinomas of the upper airways to be treated with ICI Patient who has never received treatment by ICI Informed patient who signed his consent Age > or = 18 years Social insurance Exclusion Criteria: Patient receiving corticosteroid or immunosuppressant 14 days before inclusion Immunocompromised patient Uncontrolled brain metastases Refusal to participate, patient protected by guardianship Patient unable to understand the study or unable to follow the education sessions

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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic patient education<br>Patient will receive 5 therapeutic education sessions. | Behavioral: Therapeutic education program<br>* Patient will have 5 educational therapy workshops. The first educational therapy workshops will be realized at cycle 1 and the last one within 25 weeks after starting treatment<br>|
| Active Comparator: Standard Care<br>Patient will receive usual informations | Behavioral: Usual Information<br>* Patient receive usual informations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the number of patients with at least one grade ≥ 3 immune-related Adverse Event (irAE) toxicity for 25 weeks after initiation of ICI treatment between both arm | Measure of the number of patients with at least one immune-related Adverse Event (irAE) grade ≥ 3 (CTCAE v5.0) for 25 weeks following the beginning of ICI treatment. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the toxicity of Immune Checkpoint Inhibitors (ICI) | Description of immune-related Adverse Event of grade> 2 | 36 months | 
| Quantification of ICI treatment received | Description of each cycle of ICI | 36 months | 
| Measuring the level of knowledge of patients related to the disease, the treatment and its side effects | Measuring the level of knowledge of patients with a specific questionnaire | 36 months | 
| Patients' quality of life assessment: Hospital Anxiety and Depression Scale | quality of life evaluated with the Hospital Anxiety and Depression Scale | 36 months | 
| Patients' quality of life assessment: questionnaire-C30 | quality of life evaluated with the Quality-of-life questionnaire-C30 | 36 months |