Clinical trial · Interventional
Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
NCT03948724CI-TRIAL-00124744EDHITOcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Immune Checkpoint Inhibitors | — | UNRESOLVED | — |
| Immune-related Adverse Event | — | UNRESOLVED | — |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Therapeutic Patient Education | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therapeutic education program | Behavioral | — | UNRESOLVED |
| Usual Information | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Therapeutic patient education
- description
- Patient will receive 5 therapeutic education sessions.
- interventionNames
- Behavioral: Therapeutic education program
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- Patient will receive usual informations
- interventionNames
- Behavioral: Usual Information
Primary outcomes (1)
- measure
- 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
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.