NCT03948724

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 411 (actual)
• Sponsor: Institut Cancerologie de l'Ouest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

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

Interventions

Type	Name	Description
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
BEHAVIORAL	Usual Information	Patient receive usual informations

Timeline

• Start date: 2019-12-11
• Primary completion: 2023-08-04
• Completion: 2024-08-22
• First posted: 2019-05-14
• Last updated: 2025-08-17

Locations

9 sites across 1 country: France