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Completed

NCT Number: NCT03948724

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutic education program

Behavioral

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

Usual Information

Behavioral

Patient receive usual informations

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. Characterize the toxicity of Immune Checkpoint Inhibitors (ICI)

    Time frame: 36 months

    Description of immune-related Adverse Event of grade> 2

  2. Quantification of ICI treatment received

    Time frame: 36 months

    Description of each cycle of ICI

  3. Measuring the level of knowledge of patients related to the disease, the treatment and its side effects

    Time frame: 36 months

    Measuring the level of knowledge of patients with a specific questionnaire

  4. Patients' quality of life assessment: Hospital Anxiety and Depression Scale

    Time frame: 36 months

    quality of life evaluated with the Hospital Anxiety and Depression Scale

  5. Patients' quality of life assessment: questionnaire-C30

    Time frame: 36 months

    quality of life evaluated with the Quality-of-life questionnaire-C30

Sponsors and collaborators

Lead sponsor

Institut Cancerologie de l'Ouest

Other

Registry information

Official study title

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

Acronym: EDHITO

Important dates

Study start
2019
Primary completion
2023
Study completion
2024
First posted
May 14, 2019
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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