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ETOILE : A Feasibility Study in Pediatric Patient Education

NCT ID: NCT04399863

Last Updated: 2021-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-09

Study Completion Date

2021-04-30

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.

Conditions

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Leukemia, Lymphoblastic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ETOILE therapeutic education

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.

Group Type EXPERIMENTAL

ETOILE therapeutic education

Intervention Type BEHAVIORAL

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.

Interventions

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ETOILE therapeutic education

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.

Intervention Type BEHAVIORAL

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,
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie ROUPRET-SERZEC, PharmD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

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Robert Debre Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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IDRCB: 2019-A03127-50

Identifier Type: OTHER

Identifier Source: secondary_id

APHP200113

Identifier Type: -

Identifier Source: org_study_id