Clinical trial NCT03948724: Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
Official title: Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 411
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 36 months
Secondary outcomes:
measure: Characterize the toxicity of Immune Checkpoint Inhibitors (ICI)
timeFrame: 36 months
measure: Quantification of ICI treatment received
timeFrame: 36 months
measure: Measuring the level of knowledge of patients related to the disease, the treatment and its side effects
timeFrame: 36 months
measure: Patients' quality of life assessment: Hospital Anxiety and Depression Scale
timeFrame: 36 months
measure: Patients' quality of life assessment: questionnaire-C30
timeFrame: 36 months
Other outcomes:
Locations:
city: Angers
country: France
facility: Chu Angers
city: Angers
country: France
facility: Institut de Cancerologie de L'Ouest
city: Caen
country: France
facility: Centre Francois Baclesse
city: Chambray-lès-Tours
country: France
facility: Centre D'Oncologie Et de Radiotherapie 37
city: La Roche-sur-Yon
country: France
facility: Chd Vendee
city: Lille
country: France
facility: Centre Oscar Lambret
city: Lyon
country: France
facility: Centre Leon Berard
city: Paris
country: France
facility: Institut Curie
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancerologie de Lorraine
Study officials:
affiliation: INSTITUT DE CANCEROLOGIE DE L'OUEST
name: Nathalie Beaumont
role: PRINCIPAL_INVESTIGATOR
References: