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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

Conditions

Therapeutic Patient Education Adenocarcinoma Advanced Non-Small Cell Lung Cancer Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Head and Neck Cancer Head and Neck Neoplasms Immune Checkpoint Inhibitors Immune-related Adverse Event Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Renal Cell Carcinoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Angers, Angers, France

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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. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

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 31, 2026

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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