The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
411
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
Patient receive usual informations
Chu Angers
Angers, France
Institut de Cancerologie de L'Ouest
Angers, France
Centre Francois Baclesse
Caen, France
Centre D'Oncologie Et de Radiotherapie 37
Chambray-lès-Tours, France
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.
Time frame: 36 months
Characterize the toxicity of Immune Checkpoint Inhibitors (ICI)
Description of immune-related Adverse Event of grade\> 2
Time frame: 36 months
Quantification of ICI treatment received
Description of each cycle of ICI
Time frame: 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
Time frame: 36 months
Patients' quality of life assessment: Hospital Anxiety and Depression Scale
quality of life evaluated with the Hospital Anxiety and Depression Scale
Time frame: 36 months
Patients' quality of life assessment: questionnaire-C30
quality of life evaluated with the Quality-of-life questionnaire-C30
Time frame: 36 months
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Chd Vendee
La Roche-sur-Yon, France
Centre Oscar Lambret
Lille, France
Centre Leon Berard
Lyon, France
Institut Curie
Paris, France
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, France