ETOILE : A Feasibility Study in Pediatric Patient Education

Leukemia, Lymphoblastic Clinical Trial

— ETOILE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399863
• Other study ID #: APHP200113
• Secondary ID: IDRCB: 2019-A031
• Status: Completed
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 30, 2021
• Est. primary completion date: January 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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,

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoblastic
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the ETOILE program	number of patients which joined the programme compared to number of patients referred	6 months