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The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic patient education | Experimental | Patient will receive 5 therapeutic education sessions. |
|
| Standard Care | Active Comparator | Patient will receive usual informations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic education program | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the toxicity of Immune Checkpoint Inhibitors (ICI) | Description of immune-related Adverse Event of grade> 2 | 36 months |
| Quantification of ICI treatment received | Description of each cycle of ICI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Beaumont | INSTITUT DE CANCEROLOGIE DE L'OUEST | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Angers | Angers | 49055 | France | |||
| Institut de Cancerologie de L'Ouest |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 4, 2026 | |
| Reset | May 28, 2026 | |
| Release | Jun 4, 2026 |
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| Usual Information | Behavioral | Patient receive usual informations |
|
| 36 months |
| Measuring the level of knowledge of patients related to the disease, the treatment and its side effects | Measuring the level of knowledge of patients with a specific questionnaire | 36 months |
| Patients' quality of life assessment: Hospital Anxiety and Depression Scale | quality of life evaluated with the Hospital Anxiety and Depression Scale | 36 months |
| Patients' quality of life assessment: questionnaire-C30 | quality of life evaluated with the Quality-of-life questionnaire-C30 | 36 months |
| Angers |
| 49055 |
| France |
| Centre Francois Baclesse | Caen | 14000 | France |
| Centre D'Oncologie Et de Radiotherapie 37 | Chambray-lès-Tours | 37170 | France |
| Chd Vendee | La Roche-sur-Yon | 85925 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Centre Leon Berard | Lyon | 63373 | France |
| Institut Curie | Paris | 75005 | France |
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| Reset | Jun 29, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 4, 2026 | May 28, 2026 | |||
| Jun 4, 2026 | Jun 29, 2026 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
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