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

Institut Cancerologie de l'Ouest

Status: Completed

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

Treatments: Behavioral: Usual Information; Behavioral: Therapeutic education program

Study type: Interventional

Funder types: Other

Identifiers

NCT03948724

ICO-2019-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 411 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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411 participants in 2 patient groups

Therapeutic patient education

Experimental group

Description:

Patient will receive 5 therapeutic education sessions.

Treatment:

Behavioral: Therapeutic education program

Standard Care

Active Comparator group

Description:

Patient will receive usual informations

Treatment:

Behavioral: Usual Information