We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03948724
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : May 18, 2021
Information provided by (Responsible Party):
Institut Cancerologie de l'Ouest

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

Condition or disease Intervention/treatment Phase
Therapeutic Patient Education Immune Checkpoint Inhibitors Melanoma Advanced Non-small Cell Lung Cancer Renal Cell Carcinoma Head and Neck Cancer Immune-related Adverse Event Behavioral: Therapeutic education program Behavioral: Usual Information Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
Actual Study Start Date : December 11, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023

Arm Intervention/treatment
Experimental: Therapeutic patient education
Patient follow sessions the therapeutic patient education with manual therapy, therapeutic education, therapeutic exercize
Behavioral: Therapeutic education program
Patient follow sessions the therapeutic patient education with manual therapy, therapeutic education, therapeutic exercize

Active Comparator: Standard Care
Patient receive usual informations
Behavioral: Usual Information
Patient receive usual informations

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948724

Layout table for location contacts
Contact: Virginie Berger, MD +33 241352700 virginie.berger@ico.unicancer.fr
Contact: Nathalie Beaumont +33 241352700 nathalie.beaumont@ico.unicancer.fr

Layout table for location information
Chu Angers Recruiting
Angers, France, 49055
Contact: PIERRE BIGOT, MD       pibigot@chu-angers.fr   
Chu Angers Not yet recruiting
Angers, France, 49055
Contact: YANNICK LECORRE, MD       yalecorre@chu-angers.fr   
Institut de Cancerologie de L'Ouest Recruiting
Angers, France, 49055
Contact: Nathalie BEAUMONT       nathalie.beaumont@ico.unicancer   
Centre Francois Baclesse Not yet recruiting
Caen, France, 14000
Contact: Isabelle Bonnet, MD         
Centre D'Oncologie Et de Radiotherapie 37 Not yet recruiting
Chambray-lès-Tours, France, 37170
Contact: PIERRE COMBE, md       p.combre@cort37.fr   
Centre Jean Perrin Not yet recruiting
Clermont-Ferrand, France, 63011
Contact: REGINE CHEVRIER       Regine.CHEVRIER@clermont.unicancer.fr   
Chd Vendee Not yet recruiting
La Roche-sur-Yon, France, 85925
Contact: SOPHIE LIMOUSIN       charlotte.massuyeau@chd-vendee.fr   
Centre Oscar Lambret Not yet recruiting
Lille, France, 59020
Contact: ALEXANDRA FORESTIER, MD       a-forestier@o-lambret.fr   
Centre Leon Berard Not yet recruiting
Lyon, France, 63373
Contact: MAURICE PEROL, MD       maurice.perol@lyon.unicancer.fr   
Institut Curie Not yet recruiting
Paris, France, 75005
Contact: CLAIRE LLAMBRICH-MOLINE       clairellambrichmoline@curie.fr   
Institut de Cancerologie de Lorraine Not yet recruiting
Vandœuvre-lès-Nancy, France, 54519
Contact: LIONEL GEOFFROIS, MD       l.geoffrois@nancy.unicancer.fr   
Gustave Roussy Not yet recruiting
Villejuif, France, 94800
Contact: MARILENE GUILLET-LACAZE       marilene.lacaze@gustave.roussy.fr   
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Layout table for investigator information
Principal Investigator: Nathalie Beaumont INSTITUT DE CANCEROLOGIE DE L'OUEST
Layout table for additonal information
Responsible Party: Institut Cancerologie de l'Ouest
ClinicalTrials.gov Identifier: NCT03948724    
Other Study ID Numbers: ICO-2019-02
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Renal Cell
Neoplasms by Site
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases