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

Not Applicable

Active, not recruiting

• Conditions: Immune-related Adverse Event; Immune Checkpoint Inhibitors; Melanoma; Therapeutic Patient Education; Advanced Non-small Cell Lung Cancer; Renal Cell Carcinoma; Head and Neck Cancer
• Interventions: Behavioral: Therapeutic education program; Behavioral: Usual Information

• Registration Number: NCT03948724
• Lead Sponsor: Institut Cancerologie de l'Ouest

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-14
• Study Start: 2019-12-11
• Primary Completion: 2023-08-04
• Status Verified: 2024-07
• Study Completion: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 411

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic patient education	Therapeutic education program	Patient will receive 5 therapeutic education sessions.
Standard Care	Usual Information	Patient will receive usual informations

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Characterize the toxicity of Immune Checkpoint Inhibitors (ICI)	36 months	Description of immune-related Adverse Event of grade\> 2

Trial Locations

Locations (9)

Institut de Cancerologie de L'Ouest; 🇫🇷 Angers, France

Chu Angers; 🇫🇷 Angers, France

Centre Francois Baclesse; 🇫🇷 Caen, France

Centre D'Oncologie Et de Radiotherapie 37; 🇫🇷 Chambray-lès-Tours, France

Institut Curie; 🇫🇷 Paris, France

Centre Oscar Lambret; 🇫🇷 Lille, France

Institut de Cancerologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, France

Centre Leon Berard; 🇫🇷 Lyon, France

Chd Vendee; 🇫🇷 La Roche-sur-Yon, France