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NCT Number: NCT04399863

ETOILE : A Feasibility Study in Pediatric Patient Education

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

ETOILE therapeutic education

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.

Primary outcomes

  1. Feasibility of the ETOILE program

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: ETOILE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 22, 2020
Registry last updated
Oct 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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