Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: practice adapted physical activity, control arm.
- Who it may be relevant to
- Registry conditions: Child, Only, Blood Cancer, Adapted Physical Activity, Sleep. Basic parameters: 5 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Practicing Adapted Physical Activity (APA) on Sleep Quality in Children From 5 Years of Age and Adolescents up to 16 Years of Age Undergoing Treatment for a Hematologic Malignancy.
Overview
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.
Interventions
- Behavioral practice adapted physical activity
practice daily adapted physical activity during 4 days - Other control arm
practice once adapted physical activity during 4 days
Primary outcome measures
- Quality of sleep [Time frame: the morning and the evening, from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
Secondary outcome measures (8)
- Number of sleep's hour and night awakenings [Time frame: Each night from the bedtime to the wake up time, from the bedtime of the first day to the wake up time of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
- rate of daily human physical activity in met/day [Time frame: from the morning of the first day to the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
- children quality of life [Time frame: the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
- chair stand-up test [Time frame: the morning of the first day and the morning of the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
- vigilance status description [Time frame: at 10am, 2pm and 6pm from the first day to the third day and only at 10am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
- children's pain self evaluation [Time frame: at 8am and 6pm from the first day to the third day and only at 8am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
- fatigue status [Time frame: at 10am, 2pm and 6pm from the first day to the third day and only at 10am the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
- inflammation markers [Time frame: the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU de Clermont-Ferrand — Clermont-Ferrand
Identifiers
NCT: NCT06455592 · AOI 2022 LABRAISE · 2023-A02575-40