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出境医 / 临床实验 / Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology (EDHITO)
Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology (EDHITO)
Study Description
Brief Summary:
The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Therapeutic Patient Education Immune Checkpoint Inhibitors Melanoma Advanced Non-small Cell Lung Cancer Renal Cell Carcinoma Head and Neck Cancer Immune-related Adverse Event | Behavioral: Therapeutic education program Behavioral: Usual Information | Not Applicable |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 411 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology |
| Actual Study Start Date : | December 11, 2019 |
| Estimated Primary Completion Date : | September 2022 |
| Estimated Study Completion Date : | September 2023 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Therapeutic patient education
Patient follow sessions the therapeutic patient education with manual therapy, therapeutic education, therapeutic exercize
|
Behavioral: Therapeutic education program
Patient follow sessions the therapeutic patient education with manual therapy, therapeutic education, therapeutic exercize
|
|
Active Comparator: Standard Care
Patient receive usual informations
|
Behavioral: Usual Information
Patient receive usual informations
|
Outcome Measures
Primary Outcome Measures :
- 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 [ Time Frame: 36 months ]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.
Secondary Outcome Measures :
- Characterize the toxicity of Immune Checkpoint Inhibitors (ICI) [ Time Frame: 36 months ]Description of immune-related Adverse Event of grade> 2
- Quantification of ICI treatment received [ Time Frame: 36 months ]Description of each cycle of ICI
- Measuring the level of knowledge of patients related to the disease, the treatment and its side effects [ Time Frame: 36 months ]Measuring the level of knowledge of patients with a specific questionnaire
- Patients' quality of life assessment: Hospital Anxiety and Depression Scale [ Time Frame: 36 months ]quality of life evaluated with the Hospital Anxiety and Depression Scale
- Patients' quality of life assessment: questionnaire-C30 [ Time Frame: 36 months ]quality of life evaluated with the Quality-of-life questionnaire-C30
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Contacts
| Contact: Virginie Berger, MD | +33 241352700 | virginie.berger@ico.unicancer.fr | |
| Contact: Nathalie Beaumont | +33 241352700 | nathalie.beaumont@ico.unicancer.fr |
Locations
| France | |
| Chu Angers | Recruiting |
| Angers, France, 49055 | |
| Contact: PIERRE BIGOT, MD pibigot@chu-angers.fr | |
| Chu Angers | Not yet recruiting |
| Angers, France, 49055 | |
| Contact: YANNICK LECORRE, MD yalecorre@chu-angers.fr | |
| Institut de Cancerologie de L'Ouest | Recruiting |
| Angers, France, 49055 | |
| Contact: Nathalie BEAUMONT nathalie.beaumont@ico.unicancer | |
| Centre Francois Baclesse | Not yet recruiting |
| Caen, France, 14000 | |
| Contact: Isabelle Bonnet, MD | |
| Centre D'Oncologie Et de Radiotherapie 37 | Not yet recruiting |
| Chambray-lès-Tours, France, 37170 | |
| Contact: PIERRE COMBE, md p.combre@cort37.fr | |
| Centre Jean Perrin | Not yet recruiting |
| Clermont-Ferrand, France, 63011 | |
| Contact: REGINE CHEVRIER Regine.CHEVRIER@clermont.unicancer.fr | |
| Chd Vendee | Not yet recruiting |
| La Roche-sur-Yon, France, 85925 | |
| Contact: SOPHIE LIMOUSIN charlotte.massuyeau@chd-vendee.fr | |
| Centre Oscar Lambret | Not yet recruiting |
| Lille, France, 59020 | |
| Contact: ALEXANDRA FORESTIER, MD a-forestier@o-lambret.fr | |
| Centre Leon Berard | Not yet recruiting |
| Lyon, France, 63373 | |
| Contact: MAURICE PEROL, MD maurice.perol@lyon.unicancer.fr | |
| Institut Curie | Not yet recruiting |
| Paris, France, 75005 | |
| Contact: CLAIRE LLAMBRICH-MOLINE clairellambrichmoline@curie.fr | |
| Institut de Cancerologie de Lorraine | Not yet recruiting |
| Vandœuvre-lès-Nancy, France, 54519 | |
| Contact: LIONEL GEOFFROIS, MD l.geoffrois@nancy.unicancer.fr | |
| Gustave Roussy | Not yet recruiting |
| Villejuif, France, 94800 | |
| Contact: MARILENE GUILLET-LACAZE marilene.lacaze@gustave.roussy.fr | |
Sponsors and Collaborators
Institut Cancerologie de l'Ouest
Investigators
| Principal Investigator: | Nathalie Beaumont | INSTITUT DE CANCEROLOGIE DE L'OUEST |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 10, 2019 | ||||||||
| First Posted Date ICMJE | May 14, 2019 | ||||||||
| Last Update Posted Date | May 18, 2021 | ||||||||
| Actual Study Start Date ICMJE | December 11, 2019 | ||||||||
| Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 [ Time Frame: 36 months ] 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.
|
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology | ||||||||
| Official Title ICMJE | Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology | ||||||||
| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
411 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | September 2023 | ||||||||
| Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | France | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03948724 | ||||||||
| Other Study ID Numbers ICMJE | ICO-2019-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Institut Cancerologie de l'Ouest | ||||||||
| Study Sponsor ICMJE | Institut Cancerologie de l'Ouest | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Institut Cancerologie de l'Ouest | ||||||||
| Verification Date | May 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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