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

NCT ID: NCT06455592

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-17

Study Completion Date

2027-11-30

Brief Summary

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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

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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.

Conditions

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Child, Only Blood Cancer Adapted Physical Activity Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

experimental, randomized, cross-over, single-center therapeutic trial, controlled
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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standard

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

Group Type ACTIVE_COMPARATOR

control arm

Intervention Type OTHER

practice once adapted physical activity during 4 days

daily adapted physical activity

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

Group Type EXPERIMENTAL

practice adapted physical activity

Intervention Type BEHAVIORAL

practice daily adapted physical activity during 4 days

Interventions

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practice adapted physical activity

practice daily adapted physical activity during 4 days

Intervention Type BEHAVIORAL

control arm

practice once adapted physical activity during 4 days

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuelle LABRAISE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

334.73.754.963

Facility Contacts

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Lise Laclautre

Role: primary

Other Identifiers

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2023-A02575-40

Identifier Type: OTHER

Identifier Source: secondary_id

AOI 2022 LABRAISE

Identifier Type: -

Identifier Source: org_study_id

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