Therapeutic Patient EducationEDHITONCT03948724
Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
A study testing Therapeutic education program and Usual Information in people with Therapeutic Patient Education and Immune Checkpoint Inhibitors, run by Institut Cancerologie de l'Ouest at 9 sites in France.
Trial summary
The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Therapeutic Patient Education, Immune Checkpoint Inhibitors, Melanoma
- What is being tested?
- Therapeutic education program and Usual Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 412 participants
- Where
- 9 sitesFrance
- Study dates
- 11 Dec 2019to 22 Aug 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Chu Angers
Angers, 49055
Institut de Cancerologie de L'Ouest
Angers, 49055
Centre Francois Baclesse
Caen, 14000
Centre D'Oncologie Et de Radiotherapie 37
Chambray-lès-Tours, 37170
Chd Vendee
La Roche-sur-Yon, 85925
Centre Oscar Lambret
Lille, 59020
Centre Leon Berard
Lyon, 63373
Institut Curie
Paris, 75005
Institut de Cancerologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: 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
Read the 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.
- Conditions
- Therapeutic Patient Education, Immune Checkpoint Inhibitors, Melanoma, Advanced Non-small Cell Lung Cancer, Renal Cell Carcinoma, Head and Neck Cancer
- Being tested
- Therapeutic education program, Usual Information
- Medical subject headings
- Melanoma, Carcinoma, Renal Cell, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic education programBehavioural
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 InformationBehavioural
Patient receive usual informations
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic patient education | Experimental | Patient will receive 5 therapeutic education sessions. Receives: Behavioral: Therapeutic education program |
| Standard Care | Active comparator | Patient will receive usual informations Receives: Behavioral: Usual Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 25 weeks
Secondary outcomes (4)
Number of Immune Checkpoint Inhibitor (ICI) Injections Received During the Study Period
This outcome measures the total number of immune checkpoint inhibitor (ICI) injections received by each participant over the course of the study.
Measured: 12 months
Anxiety Level Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
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.
Measured: 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
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.
Measured: 12 months
Depressionlevel Assessed by the Hospital Anxiety and Depression Scale (HADS-A)
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start11 Dec 2019
- Primary completion4 Aug 2023
- Study completion22 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Therapeutic Patient EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 412 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie Beaumont, Principal investigator, INSTITUT DE CANCEROLOGIE DE L'OUEST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948724
- Sponsor's protocol ID
- ICO-2019-02
- Acronym
- EDHITO
- Status last verified
- May 2026
- First submitted
- 10 May 2019
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No