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NCT03948724 Clinical Trial

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

Head and Neck Cancer Clinical Trial

— EDHITO  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03948724
Other study ID # ICO-2019-02
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date December 11, 2019
Est. completion date February 2024

Study information
Verified date August 2023
Source Institut Cancerologie de l'Ouest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 411
Est. completion date February 2024
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Therapeutic education program
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
• Usual Information
Patient receive usual informations

Locations
Country Name City State
France 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 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

Sponsors (1)
Lead Sponsor Collaborator
Institut Cancerologie de l'Ouest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Characterize the toxicity of Immune Checkpoint Inhibitors (ICI) Description of immune-related Adverse Event of grade> 2 36 months
Secondary Quantification of ICI treatment received Description of each cycle of ICI 36 months
Secondary 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
Secondary Patients' quality of life assessment: Hospital Anxiety and Depression Scale quality of life evaluated with the Hospital Anxiety and Depression Scale 36 months
Secondary Patients' quality of life assessment: questionnaire-C30 quality of life evaluated with the Quality-of-life questionnaire-C30 36 months
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