Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years (APANYX)

University Hospital, Clermont-Ferrand

Status: Enrolling

Conditions: Child, Only; Blood Cancer; Adapted Physical Activity; Sleep

Treatments: Behavioral: practice adapted physical activity; Other: control arm

Study type: Interventional

Funder types: Other

Identifiers

NCT06455592

2023-A02575-40 (Other Identifier)

AOI 2022 LABRAISE

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

standard

Active Comparator group

Description:

practice only once adapted physical activity in hospital and at home during four days

Treatment:

Other: control arm

daily adapted physical activity

Experimental group

Description:

practice adapted physical activity daily in hospital and at home during four days

Treatment:

Behavioral: practice adapted physical activity