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:
Turku University Hospital
Organization:
Study Overview
Official Title:
Effective Implementation of the Physical Activity and Motor Skills Intervention for 3-6-year-old Children With Cancer (EMPOWER)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER
Brief Summary:
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.
Detailed Description:
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.
The 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.
In order to reach these objectives, EMPOWER sets the following research questions for itself:
1. 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?
2. 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)
3. What factors affect the sustainability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
4. What is the association of intervention on physical activity and motor performance of children aged 3-6 years?
5. 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.
The 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.
In order to reach these objectives, EMPOWER sets the following research questions for itself:
1. 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?
2. 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)
3. What factors affect the sustainability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
4. What is the association of intervention on physical activity and motor performance of children aged 3-6 years?
5. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 368294 | OTHER_GRANT | Finnish Academy, ACTIVE programme | View |