ETOILE : A Feasibility Study in Pediatric Patient Education

Study Overview
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Brief Summary
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Feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital ( Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will be assessed.

Detailed Description
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This is a pilot feasibility study, of the quasi-experimental before-after, non-randomized, mono-centric type. Feasibility is assessed on process criteria (adoption, reach implementation, satisfaction). Intermediate effectiveness is assessed on the skill level of patients and their caregivers, before, after and at a distance from education. Patients' anxiety levels will also be assessed before, after and at a distance from the program. The level of health literacy will be assessed at the start of the study.

Official Title
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Feasibility Study of the ETOILE Program, a Therapeutic Education Program in Pediatric Hematology About Acute Lymphoblastic Leukemia and Allogenic Hematopoietic Steam Cells Transplantation, for Patient and Caregivers

Conditions
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Leukemia, Lymphoblastic

Intervention / Treatment
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* Behavioral: ETOILE therapeutic education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Criteria relating to the population studied: child between 0 and 18 years old, followed at Robert Debré hospital (Paris), by a doctor from the hematology and immunology department Of which the 2 holders of parental authority have been informed and have signed the consent Having 1 or 2 caregivers available to accompany him during FTE sessions 1 to 2 of their adult caregivers will be eligible for the ETOILE program and will be included in the study after their consent. Child with acute lymphoblastic leukemia, treated at Robert Debré Hospital (Paris), in the induction or consolidation phase Child going to receive or having received an allograft of hematopoietic stem cells at the Robert Debré hospital (Paris) Beneficiaries of a social security scheme or entitled to it, Exclusion Criteria: Child not mastering the French language, Child with physical or cognitive disability to participate in the program,

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ETOILE therapeutic education<br>ETOILE is a patient education program, in accordance with French recommendations, which offers to patients and caregivers the opportunity to follow a customized educational training on their disease. Better quality of life and enhanced autonomy are the aim of this program. | Behavioral: ETOILE therapeutic education<br>* ETOILE is a patient education program, in accordance with French recommendations, which offers to patients and caregivers the opportunity to follow a customized educational training on their disease. Better quality of life and enhanced autonomy are the aim of this program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the ETOILE program | number of patients which joined the programme compared to number of patients referred | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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therapeutic education