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

August 28, 2026 updated by: Institut Cancerologie de l'Ouest

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

412

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49055
        • Institut de Cancérologie de l'Ouest
      • Angers, France, 49055
        • CHU Angers
      • Caen, France, 14000
        • Centre François Baclesse
      • Chambray-lès-Tours, France, 37170
        • Centre D'Oncologie Et de Radiotherapie 37
      • La Roche-sur-Yon, France, 85925
        • CHD Vendée
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Lyon, France, 63373
        • Centre Léon Bérard
      • Paris, France, 75005
        • Institut Curie
      • Vandœuvre-lès-Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapeutic patient education
Patient will receive 5 therapeutic education sessions.
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
Active Comparator: Standard Care
Patient will receive usual informations
Behavioral: Usual Information
Patient receive usual informations

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants With at Least One Grade ≥3 Immune-related Adverse Event (irAE) (CTCAE v5.0) Within 25 Weeks After Initiation of Immune Checkpoint Inhibitor (ICI) Treatment
Time Frame: 25 weeks
The primary outcome is the occurrence of at least one immune-related adverse event (irAE) of Grade ≥3, as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, during the 25 weeks following initiation of immune checkpoint inhibitor (ICI) treatment. This outcome is compared between the experimental group receiving Therapeutic Patient Education (TPE) and the control group receiving usual information.
25 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Immune Checkpoint Inhibitor (ICI) Injections Received During the Study Period
Time Frame: 12 months
This outcome measures the total number of immune checkpoint inhibitor (ICI) injections received by each participant over the course of the study.
12 months
Anxiety Level Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
Time Frame: 12 months

This outcome assesses patients' anxiety level using the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A), a validated self-report instrument designed to measure the severity of anxiety symptoms in medical populations.

The HADS-A subscale consists of 7 items, each scored from 0 to 3, yielding a total score ranging from 0 to 21.

Minimum score: 0 (no anxiety symptoms) Maximum score: 21 (maximum anxiety severity)

Interpretation:

Lower scores indicate better outcomes (lower anxiety levels). Higher scores indicate worse outcomes (greater anxiety symptoms).

Scores are calculated as the sum of the 7 item scores. Results will be compared between treatment groups at the specified time point.ps.
12 months
Global Health Status/Quality of Life Assessed by Thethe European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Questionnaire
Time Frame: 12 months

This outcome evaluates patients' overall quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), a validated cancer-specific instrument assessing multiple dimensions of quality of life.

The Global Health Status/Quality of Life scale of the EORTC QLQ-C30 is based on 2 items, each scored from 1 to 7. Raw scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual.

Minimum score (transformed): 0 Maximum score (transformed): 100

Interpretation:

Higher scores indicate better outcomes (better overall quality of life and global health status).

Lower scores indicate worse outcomes (poorer quality of life).

The final score is calculated by averaging the item scores and applying a linear transformation to a 0-100 scale.

Results will be compared between treatment groups at the specified time point.
12 months
Depressionlevel Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
Time Frame: 12 months

his outcome assesses patients' depression level using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D), a validated self-report instrument designed to measure the severity of depressive symptoms in medical populations.

The HADS-D subscale consists of 7 items, each scored from 0 to 3, yielding a total score ranging from 0 to 21.

Minimum score: 0 (no depressive symptoms) Maximum score: 21 (maximum depression severity)

Interpretation:

Lower scores indicate better outcomes (lower levels of depression). Higher scores indicate worse outcomes (greater depressive symptoms).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Cancerologie de l'Ouest

Investigators

  • Principal Investigator: Nathalie Beaumont, Institut de Cancérologie de l'Ouest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2019

Primary Completion (Actual)

August 4, 2023

Study Completion (Actual)

August 22, 2024

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICO-2019-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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