ETOILE : A Feasibility Study in Pediatric Patient Education

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Leukemia, Lymphoblastic

Treatments: Behavioral: ETOILE therapeutic education

Study type: Interventional

Funder types: Other

Identifiers

NCT04399863

APHP200113

IDRCB: 2019-A03127-50 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ETOILE therapeutic education

Experimental group

Description:

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.

Treatment:

Behavioral: ETOILE therapeutic education