NCT04399863

ETOILE : A Feasibility Study in Pediatric Patient Education

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Lymphoblastic

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-09
• Primary completion: 2021-01-02
• Completion: 2021-04-30
• First posted: 2020-05-22
• Last updated: 2021-10-18

Locations

1 site across 1 country: France