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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Sleep; Child, Only; Blood Cancer; Adapted Physical Activity
• Intervention / Treatment: Other: control arm; Behavioral: practice adapted physical activity

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU de Clermont-Ferrand
    • Contact: Lise LACLAUTRE
    • Principal Investigator: Emmanuelle LABRAISE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard; practice only once adapted physical activity in hospital and at home during four days	Other: control arm; practice once adapted physical activity during 4 days
Experimental: daily adapted physical activity; practice adapted physical activity daily in hospital and at home during four days	Behavioral: practice adapted physical activity; practice daily adapted physical activity during 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of sleep	daily calendar with information about child's sleep complete by parents	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

Outcome Measure	Measure Description	Time Frame
Number of sleep's hour and night awakenings	wear a sleep recorder during the night	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	wear a wearable device allday and night long	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	parent-completed questionnaire	the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days
chair stand-up test	maximum sit-up and stand-up from a chair during one minute	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	parent-completed questionnaire	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	self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score	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	parent-completed questionnaire	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	C reactive protein and IL6 from daily blood test	the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Emmanuelle LABRAISE, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: sleep; child; adapted physical activity; blood cancer; hospital and home
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: AOI 2022 LABRAISE; 2023-A02575-40 (Other Identifier: 2023-A02575-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No