NCT03948724

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

December 11, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 4, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2024

Completed
Last Updated

August 17, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

May 10, 2019

Last Update Submit

August 13, 2025

Conditions

Therapeutic Patient EducationImmune Checkpoint InhibitorsMelanomaAdvanced Non-small Cell Lung CancerRenal Cell CarcinomaHead and Neck CancerImmune-related Adverse Event

Outcome Measures

Primary Outcomes (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

    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.

    36 months

Secondary Outcomes (5)

  • Characterize the toxicity of Immune Checkpoint Inhibitors (ICI)

    36 months

  • Quantification of ICI treatment received

    36 months

  • Measuring the level of knowledge of patients related to the disease, the treatment and its side effects

    36 months

  • Patients' quality of life assessment: Hospital Anxiety and Depression Scale

    36 months

  • Patients' quality of life assessment: questionnaire-C30

    36 months

Study Arms (2)

Therapeutic patient education

EXPERIMENTAL

Patient will receive 5 therapeutic education sessions.

Behavioral: Therapeutic education program

Standard Care

ACTIVE COMPARATOR

Patient will receive usual informations

Behavioral: Usual Information

Interventions

Therapeutic education programBEHAVIORAL

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

Therapeutic patient education
Usual InformationBEHAVIORAL

Patient receive usual informations

Standard Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Chu Angers

Angers, 49055, France

Location

Institut de Cancerologie de L'Ouest

Angers, 49055, France

Location

Centre Francois Baclesse

Caen, 14000, France

Location

Centre D'Oncologie Et de Radiotherapie 37

Chambray-lès-Tours, 37170, France

Location

Chd Vendee

La Roche-sur-Yon, 85925, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Leon Berard

Lyon, 63373, France

Location

Institut Curie

Paris, 75005, France

Location

Institut de Cancerologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

MelanomaCarcinoma, Renal CellHead and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Nathalie Beaumont

    INSTITUT DE CANCEROLOGIE DE L'OUEST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2019

First Posted

May 14, 2019

Study Start

December 11, 2019

Primary Completion

August 4, 2023

Study Completion

August 22, 2024

Last Updated

August 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(9)