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Trial Title:
Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years
NCT ID:
NCT06455592
Condition:
Child, Only
Blood Cancer
Adapted Physical Activity
Sleep
Conditions: Official terms:
Hematologic Neoplasms
Conditions: Keywords:
child
blood cancer
adapted physical activity
sleep
hospital and home
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Intervention model description:
experimental, randomized, cross-over, single-center therapeutic trial, controlled
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
practice adapted physical activity
Description:
practice daily adapted physical activity during 4 days
Arm group label:
daily adapted physical activity
Intervention type:
Other
Intervention name:
control arm
Description:
practice once adapted physical activity during 4 days
Arm group label:
standard
Summary:
Main objective :
Evaluate the effect of adapted physical activity on the sleep of children with cancer
from 5 to 16
Hypothesis :
Practice daily adapted physical activity improve the sleep of the 5 to 16 children with
cancer
Detailed description:
Medical process are leading to an increase in the survival of children/adolescents
undergoing treatment for blood cancer. Caregivers need to focus on optimizing these
patients' quality of life during and after the disease. Sleep is essential to their
development. Sleep disorders are symptoms reported by patients. They have a negative
impact on their quality of life. Adapted physical activity sessions are offered in
pediatric oncology departments, but sedentary behavior persists. The hypothesis is that
the daily practice of adapted physical activity will improve sleep in patients treated
for blood cancer.
This is a randomized, cross-over, open-label, two-armed parallel, unique center
therapeutic trial comparing the effect of practice adapted physical activity only once
during four days (conventional strategy) versus practice adapted physical activity each
day during four days (experimental strategy) on the sleep of the children with blood
cancer from 5 to 16 at the hospital in Clermont-Ferrand and at home.
The study will last four weeks with a wash-out week after 2 weeks. The outcomes are
described later. The nurse informs and obtains the consent of the child and his parents.
After statistical analysis of these two arms, it will be possible to determine the value
of practice daily adapted physical activity on the sleep of children with blood cancer
from 5 to 16 at the hospital and at home.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Children from 5 to 16 with haematological cancer undergoing treatment
- Subjects and their parents who were informed about the study and gave informed
consent.
- Enrollment in the Social Security system
Exclusion Criteria:
- Children on high-dose corticosteroids
- Children under anxiolytic treatment
- Children with sleep disorders (sleep apnea)
- Children taking melatonin or sleeping pills
- Contraindication to adapted physical activity
- Refusal to participate on the part of the participant or his/her parents
- Holders of parental authority under curatorship, guardianship, safeguard of justice
- Pregnant or breast-feeding teenagers
Gender:
All
Minimum age:
5 Years
Maximum age:
16 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Clermont-Ferrand
Address:
City:
Clermont-Ferrand
Country:
France
Contact:
Last name:
Lise Laclautre
Investigator:
Last name:
Emmanuelle LABRAISE
Email:
Principal Investigator
Start date:
September 2024
Completion date:
September 2026
Lead sponsor:
Agency:
University Hospital, Clermont-Ferrand
Agency class:
Other
Source:
University Hospital, Clermont-Ferrand
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06455592
