ETOILE : A Feasibility Study in Pediatric Patient Education

NCT04399863 | Completed

• 2 other identifiers: APHP200113IDRCB: 2019-A03127-50
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Lymphoblastic

Keywords

therapeutic education

Outcome Measures

Primary Outcomes (1)

• Feasibility of the ETOILE program

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

  6 months

Study Arms (1)

ETOILE therapeutic education

EXPERIMENTAL

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.

Behavioral: ETOILE therapeutic education

Interventions

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.

ETOILE therapeutic education

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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,

You may not qualify if:

• Child not mastering the French language,
• Child with physical or cognitive disability to participate in the program,

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Julie ROUPRET-SERZEC, PharmD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 22, 2020
• Study Start: July 9, 2020
• Primary Completion: January 2, 2021
• Study Completion: April 30, 2021
• Last Updated: October 18, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)