Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:52 AM
Study NCT ID:
NCT07488494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effective Implementation of the Physical Activity and Motor Skills Intervention for 3-6-year-old Children With Cancer (EMPOWER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Amount of child's daily physical activity is measured by parents reporting to their mobile EMPOWER user interface.", 'timeFrame': 'From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).', 'description': "Child's physical activity is measured daily by using the mobile EMPOWER user interface over the intervention. This tool has been created by Turku University of applied sciences for this study."}, {'measure': 'Age-appropriate motor skills are measured by Movement ABC measuring system', 'timeFrame': 'From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).', 'description': "Motor skills are tested using Movement ABC-measuring system (version 3) monthly up to 3 months ande there after every 3 months (depending on the length of child's cancer treatment."}, {'measure': 'Quality of life of the child is measured by internationally validated Pedatric Quality of Life Inventory (PedsQoL)', 'timeFrame': 'From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).', 'description': 'Quality of life of the child is measured by using age-appropriate Generic Core scales of PedsQoL parent proxy forms.'}, {'measure': "Fibion SENS device is used for continuous measuring of the child's activity over 7 days.", 'timeFrame': 'From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).', 'description': 'Fibion SENS activity measurement is performed ovet 7 days all together three times during the whole intervention.'}, {'measure': 'Feasibility of using the mobile EMPOWER application is explored by interviewing the parents/caregivers', 'timeFrame': 'From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).', 'description': 'Parents/caregivers of the participating children are interviewed three times during the study period using semi-structured method developed by the study team.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physical activity enhancement'], 'conditions': ['Physical Activity During Cancer Treatment']}, 'referencesModule': {'references': [{'pmid': '33538309', 'type': 'BACKGROUND', 'citation': 'Wurz A, McLaughlin E, Lategan C, Ellis K, Culos-Reed SN. Synthesizing the literature on physical activity among children and adolescents affected by cancer: evidence for the international Pediatric Oncology Exercise Guidelines (iPOEG). Transl Behav Med. 2021 Apr 7;11(3):699-708. doi: 10.1093/tbm/ibaa136.'}]}, 'descriptionModule': {'briefSummary': "The study examines the association of digitally provided EMPOWER - exercise intervention on 3-6-year-old child's physical activity (PA), motor performance and quality of life (QoL) during and after cancer treatment. In addition, the factors that influence the feasibility of the intervention will be examined. The research is carried out in cooperation with Turku University of Applied Sciences, Turku and Tampere University Hospitals. Cancer treatments significantly reduce the amount of PA of the child impairing the normal motor development. Delay in normal motor development may cause childhood cancer survivors a higher risk of developing adverse health effects in adulthood. Data on children's PA and condition is collected using questionnaires and sensors. In addition, children's motor performance and QoL are examined through tests and questionnaires. The feasibility of the intervention will be examined from the parents and nursing staff through questionnaires and interviews.", 'detailedDescription': "The previous exercise guidelines for children with cancer indicate that physical activity is advisable during cancer treatments. However, it has been noted that while the effects of exercise interventions on various health variables in children with cancer have been found effective, there is a recognized need to further investigate the barriers of exercise interventions. The research project will gather new empirical data, thus providing opportunities for understand implementation of evidence-based recommendations in the studied context.\n\nThe objectives are: 1) to investigate the association of planned technology-enhanced exercise guidance on child's physical activity, motor performance and quality of life during the cancer treatment and 6 and 12 months after the intensive treatment period 2) to investigate, which factors have effect on exercise intervention's acceptability, fidelity, sustainability and feasibility.\n\nIn order to reach these objectives, EMPOWER sets the following research questions for itself:\n\n1. What factors affect the feasibility and the acceptability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?\n2. What factors affect the degree to which an intervention improving physical activity and motor skills during the cancer treatment on 3-6-year-old children, was implemented as prescribed or intended (Fidelity)\n3. What factors affect the sustainability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?\n4. What is the association of intervention on physical activity and motor performance of children aged 3-6 years?\n5. What is the association of intervention on daily condition, and quality of life of children aged 3-6 years? This study addresses the following main hypothesis: Physical exercise during cancer treatment enables a child to keep PA level and motor performance age-appropriate at the end of cancer treatment. Another hypothesis is that support and guidance to the nursing staff and care givers on the significance of and methods of implementing the PA intervention, will enhance the intervention's fidelity and acceptability, feasibility and sustainability. Additionally, a hypothesis is that feedback on the child's condition during the treatment period will encourage and help the child and her guardians to implement the PA intervention during treatment. A further hypothesis is that physical exercise will not worsen the child's condition and quality of life during and after cancer treatment but might even promote them."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nCancer diagnosis at the age of 3 to 6 years\n\nExclusion Criteria:\n\nNo heart disease or neurological condition prohibiting physical activity -'}, 'identificationModule': {'nctId': 'NCT07488494', 'acronym': 'EMPOWER', 'briefTitle': 'Effective Implementation of the Physical Activity and Motor Skills Intervention for 3-6-year-old Children With Cancer (EMPOWER)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Effective Implementation of the Physical Activity and Motor Skills Intervention for 3-6-year-old Children With Cancer (EMPOWER)', 'orgStudyIdInfo': {'id': '60230'}, 'secondaryIdInfos': [{'id': '368294', 'type': 'OTHER_GRANT', 'domain': 'Finnish Academy, ACTIVE programme'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'EMPOWER intervention', 'description': 'a single arm study', 'interventionNames': ['Behavioral: Digital tool for physical activity guidance and follow-up', 'Behavioral: Physical activity guidance']}], 'interventions': [{'name': 'Digital tool for physical activity guidance and follow-up', 'type': 'BEHAVIORAL', 'description': 'Intervention length applied in this study varies according to participants cancer type and treatment period from 6 to 12 months. The intervention is carried out by mixed supervision. During the hospital visits supervision is carried out by experienced exercise physiotherapist together with the parents. During the home periods the supervision is carried out by EMPOWER mobile user interface.\n\nThe recommended minimum three hours of PA a day for children consist of age appropriate activities of different ranges of intensity: 2 hours of light or brisk physical activity and one hour vigorous physical activity. Targeted single PA session duration is ≥30 min and the progression of the PA dose (exercise frequency, duration) and especially intensity, is expected to increase gradually up to 3 hours / day considering the child + parent self-evaluated daily condition.', 'armGroupLabels': ['EMPOWER intervention']}, {'name': 'Physical activity guidance', 'type': 'BEHAVIORAL', 'description': "The intervention will be delivered by EMPOWER mobile UI for self reporting as well as guiding parents based on data. The application is adapted from an existing MyE.Way knowledge management system for holistic player development in team sports. EMPOWER mobile UI data collection and guidance system gives daily reminder to the parents about the daily PA recommendation. In addition, the families are provided with educational tips on useful games and activities leading to light, brisk, or vigorous PA. The tips are adjusted so that they can be completed during the cancer treatment either indoors or outdoors. The provided activities include education concerning the safety aspects regarding the child's cancer type and cancer treatment. As part of the intervention, children's daily pain, condition and exercise enjoyment, as well as child's readiness for exercise will be evaluated via the tool", 'armGroupLabels': ['EMPOWER intervention']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Finnish legislation does not allow person level data to be delivered outside the study group'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Turku University of Applied Sciences', 'class': 'UNKNOWN'}, {'name': 'Tampere University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}