Loading clinical trials...
Loading clinical trials...
Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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, France
Start Date
December 11, 2019
Primary Completion Date
August 4, 2023
Completion Date
August 22, 2024
Last Updated
August 17, 2025
411
ACTUAL participants
Therapeutic education program
BEHAVIORAL
Usual Information
BEHAVIORAL
Lead Sponsor
Institut Cancerologie de l'Ouest
NCT05039801
NCT06066138
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions