EDHITO: Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
Study Details
Study Description
Brief Summary
The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Therapeutic patient education Patient follow sessions the therapeutic patient education with manual therapy, therapeutic education, therapeutic exercize |
Behavioral: Therapeutic education program
Patient follow sessions the therapeutic patient education with manual therapy, therapeutic education, therapeutic exercize
|
| Active Comparator: Standard Care Patient receive usual informations |
Behavioral: Usual Information
Patient receive usual informations
|
Outcome Measures
Primary Outcome Measures
- 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 [36 months]
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.
Secondary Outcome Measures
- Characterize the toxicity of Immune Checkpoint Inhibitors (ICI) [36 months]
Description of immune-related Adverse Event of grade> 2
- Quantification of ICI treatment received [36 months]
Description of each cycle of ICI
- Measuring the level of knowledge of patients related to the disease, the treatment and its side effects [36 months]
Measuring the level of knowledge of patients with a specific questionnaire
- Patients' quality of life assessment: Hospital Anxiety and Depression Scale [36 months]
quality of life evaluated with the Hospital Anxiety and Depression Scale
- Patients' quality of life assessment: questionnaire-C30 [36 months]
quality of life evaluated with the Quality-of-life questionnaire-C30
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient with Melanoma, Non-Small Cell Bronchial Cancer, renal cell carcinoma, Ca carcinomas of the upper airways to be treated with ICI
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Patient who has never received treatment by ICI
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Informed patient who signed his consent
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Age > or = 18 years
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Social insurance
Exclusion Criteria:
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Patient receiving corticosteroid or immunosuppressant 14 days before inclusion
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Immunocompromised patient
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Uncontrolled brain metastases
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Refusal to participate, patient protected by guardianship
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Patient unable to understand the study or unable to follow the education sessions
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Angers | Angers | France | 49055 | |
| 2 | Chu Angers | Angers | France | 49055 | |
| 3 | Institut de Cancerologie de L'Ouest | Angers | France | 49055 | |
| 4 | Centre Francois Baclesse | Caen | France | 14000 | |
| 5 | Centre D'Oncologie Et de Radiotherapie 37 | Chambray-lès-Tours | France | 37170 | |
| 6 | Centre Jean Perrin | Clermont-Ferrand | France | 63011 | |
| 7 | Chd Vendee | La Roche-sur-Yon | France | 85925 | |
| 8 | Centre Oscar Lambret | Lille | France | 59020 | |
| 9 | Centre Leon Berard | Lyon | France | 63373 | |
| 10 | Institut Curie | Paris | France | 75005 | |
| 11 | Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | France | 54519 | |
| 12 | Gustave Roussy | Villejuif | France | 94800 |
Sponsors and Collaborators
- Institut Cancerologie de l'Ouest
Investigators
- Principal Investigator: Nathalie Beaumont, INSTITUT DE CANCEROLOGIE DE L'OUEST
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICO-2019-02