ETOILE : A Feasibility Study in Pediatric Patient Education

Not Applicable

Completed

• Conditions: Leukemia, Lymphoblastic
• Interventions: Behavioral: ETOILE therapeutic education

• Registration Number: NCT04399863
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-11
• Study First Submitted QC: 2020-05-19
• Study First Posted: 2020-05-22
• Study Start: 2020-07-09
• Primary Completion: 2021-01-02
• Study Completion: 2021-04-30
• Last Update Submitted: 2021-10-15
• Last Update Posted: 2021-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ETOILE therapeutic education	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.

Primary Outcome Measures

Name	Time	Method
Feasibility of the ETOILE program	6 months	number of patients which joined the programme compared to number of patients referred

Trial Locations

Locations (1)

Robert Debre Hospital; 🇫🇷 Paris, France