Back to resultsETOILE : A Feasibility Study in Pediatric Patient Education (ETOILE)
Primary Purpose
Leukemia, Lymphoblastic
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ETOILE therapeutic education
Sponsored by
About this trial
This is an interventional supportive care trial for Leukemia, Lymphoblastic focused on measuring therapeutic education
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,
Sites / Locations
- Robert Debre Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ETOILE therapeutic education
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility of the ETOILE program
number of patients which joined the programme compared to number of patients referred
Secondary Outcome Measures
Full Information
NCT ID
NCT04399863
First Posted
May 11, 2020
Last Updated
October 15, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04399863
Brief Title
ETOILE : A Feasibility Study in Pediatric Patient Education
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 9, 2020 (Actual)
Primary Completion Date
January 2, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoblastic
Keywords
therapeutic education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ETOILE therapeutic education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ETOILE therapeutic education
Intervention Description
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 Outcome Measure Information:
Title
Feasibility of the ETOILE program
Description
number of patients which joined the programme compared to number of patients referred
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie ROUPRET-SERZEC, PharmD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Debre Hospital
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
ETOILE : A Feasibility Study in Pediatric Patient Education
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