Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-05 @ 7:52 AM
Study NCT ID:
NCT06455592
Status:
RECRUITING
Last Update Posted:
2025-12-05
First Post:
2024-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'experimental, randomized, cross-over, single-center therapeutic trial, controlled'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2024-05-31', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of sleep', 'timeFrame': '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', 'description': "daily calendar with information about child's sleep complete by parents"}], 'secondaryOutcomes': [{'measure': "Number of sleep's hour and night awakenings", 'timeFrame': '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', 'description': 'wear a sleep recorder during the night'}, {'measure': 'rate of daily human physical activity in met/day', 'timeFrame': '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', 'description': 'wear a wearable device allday and night long'}, {'measure': 'children quality of life', 'timeFrame': 'the morning the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days', 'description': 'parent-completed questionnaire'}, {'measure': 'chair stand-up test', 'timeFrame': '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', 'description': 'maximum sit-up and stand-up from a chair during one minute'}, {'measure': 'vigilance status description', 'timeFrame': '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', 'description': 'parent-completed questionnaire'}, {'measure': "children's pain self evaluation", 'timeFrame': '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', 'description': "self evaluation of children's pain with the visial analog scale in vertical position quote from 0 to 10, 10=worst score"}, {'measure': 'fatigue status', 'timeFrame': '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', 'description': 'parent-completed questionnaire'}, {'measure': 'inflammation markers', 'timeFrame': 'the morning, from the first and the fourth day, during the 2 sessions of 2 cycles, each cycle is 4 days', 'description': 'C reactive protein and IL6 from daily blood test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['child', 'blood cancer', 'adapted physical activity', 'sleep', 'hospital and home'], 'conditions': ['Child, Only', 'Blood Cancer', 'Adapted Physical Activity', 'Sleep']}, 'descriptionModule': {'briefSummary': 'Main objective :\n\nEvaluate the effect of adapted physical activity on the sleep of children with cancer from 5 to 16\n\nHypothesis :\n\nPractice daily adapted physical activity improve the sleep of the 5 to 16 children with cancer', 'detailedDescription': "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.\n\nThis 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children from 5 to 16 with haematological cancer undergoing treatment\n* Subjects and their parents who were informed about the study and gave informed consent.\n* Enrollment in the Social Security system\n\nExclusion Criteria:\n\n* Children on high-dose corticosteroids\n* Children under anxiolytic treatment\n* Children with sleep disorders (sleep apnea)\n* Children taking melatonin or sleeping pills\n* Contraindication to adapted physical activity\n* Refusal to participate on the part of the participant or his/her parents\n* Holders of parental authority under curatorship, guardianship, safeguard of justice\n* Pregnant or breast-feeding teenagers'}, 'identificationModule': {'nctId': 'NCT06455592', 'acronym': 'APANYX', 'briefTitle': 'Effect of APA on Sleep Quality in Children With Cancer From 5 to 16 Years', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'AOI 2022 LABRAISE'}, 'secondaryIdInfos': [{'id': '2023-A02575-40', 'type': 'OTHER', 'domain': '2023-A02575-40'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'standard', 'description': 'practice only once adapted physical activity in hospital and at home during four days', 'interventionNames': ['Other: control arm']}, {'type': 'EXPERIMENTAL', 'label': 'daily adapted physical activity', 'description': 'practice adapted physical activity daily in hospital and at home during four days', 'interventionNames': ['Behavioral: practice adapted physical activity']}], 'interventions': [{'name': 'practice adapted physical activity', 'type': 'BEHAVIORAL', 'description': 'practice daily adapted physical activity during 4 days', 'armGroupLabels': ['daily adapted physical activity']}, {'name': 'control arm', 'type': 'OTHER', 'description': 'practice once adapted physical activity during 4 days', 'armGroupLabels': ['standard']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT'}, {'name': 'Emmanuelle LABRAISE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Lise Laclautre', 'role': 'CONTACT', 'email': 'promo_interne_drci@chu-clermontferrand.fr', 'phone': '334.73.754.963'}], 'overallOfficials': [{'name': 'Emmanuelle LABRAISE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}