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Clinical Trials/NCT04399863
NCT04399863
Completed
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country10 target enrollmentJuly 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia, Lymphoblastic
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
10
Locations
1
Primary Endpoint
Feasibility of the ETOILE program
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 9, 2020
End Date
April 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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,

Outcomes

Primary Outcomes

Feasibility of the ETOILE program

Time Frame: 6 months

number of patients which joined the programme compared to number of patients referred

Study Sites (1)

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