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Can teaching patients about immunotherapy cut severe side effects?

NCT ID NCT03948724

Symptom relief Sponsor: Institut Cancerologie de l'Ouest Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether a structured patient education program can lower the risk of severe immune-related side effects in people receiving immunotherapy for certain cancers, including melanoma, lung, kidney, and head and neck cancers. Participants either attend five educational workshops or receive standard information. The study tracks how many people develop grade 3 or higher side effects within 25 weeks of starting treatment, along with anxiety levels and the number of immunotherapy doses received.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Therapeutic patient education program (behavioral intervention)
What this could lead to
If it works, this program could help people on immunotherapy experience fewer severe side effects, making treatment more tolerable and potentially improving quality of life.
What could go wrong
The trial is early and the outcome depends on whether education alone can meaningfully change side-effect rates. It may not reduce severe immune reactions, and results may not apply to all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

412 people

The number who actually took part.

Started

Dec 2019

Finished

Aug 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck cancer Head and Neck Neoplasms melanoma non-small cell lung carcinoma renal cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced non-small cell lung cancer Head and neck cancer Immune checkpoint inhibitors Immune-related adverse event Melanoma Renal cell carcinoma Therapeutic patient education

Contacts and locations

Locations

  • Centre D'Oncologie Et de Radiotherapie 37

    Chambray-lès-Tours, 37170, France

  • Centre Francois Baclesse

    Caen, 14000, France

  • Centre Leon Berard

    Lyon, 63373, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Chd Vendee

    La Roche-sur-Yon, 85925, France

  • Chu Angers

    Angers, 49055, France

  • Institut Curie

    Paris, 75005, France

  • Institut de Cancerologie de L'Ouest

    Angers, 49055, France

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519, France

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