Advanced Non-small Cell Lung Cancer, Head and Neck Cancer, Immune Checkpoint Inhibitors, Immune-related Adverse Event, Melanoma, Renal Cell Carcinoma, Therapeutic Patient Education
Conditions
Brief summary
The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI
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.
Interventions
BEHAVIORALTherapeutic 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
BEHAVIORALUsual Information
Patient receive usual informations
Sponsors
Institut Cancerologie de l'Ouest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Immune Checkpoint Inhibitor (ICI) Injections Received During the Study Period | 12 months | This outcome measures the total number of immune checkpoint inhibitor (ICI) injections received by each participant over the course of the study. |
| Anxiety Level Assessed by the Hospital Anxiety and Depression Scale (HADS-A) | 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. |
| 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 | 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. |
| Depressionlevel Assessed by the Hospital Anxiety and Depression Scale (HADS-A) | 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). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNathalie Beaumont
INSTITUT DE CANCEROLOGIE DE L'OUEST
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 77 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants |
| Race and Ethnicity Not Collected | 0 Participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 269 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 275 | 4 / 137 |
| other Total, other adverse events | 81 / 275 | 34 / 137 |
| serious Total, serious adverse events | 0 / 275 | 0 / 137 |
Outcome results
None listed