Effective Implementation of the Physical Activity and Motor Skills Intervention for 3-6-year-old Children With Cancer (EMPOWER)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Amount of child's daily physical activity is measured by parents reporting to their mobile EMPOWER user interface.
研究概览
简要总结
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.
详细描述
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:
- 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?
- 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)
- What factors affect the sustainability of an intervention improving physical activity and motor skills of 3-6-year-old children with cancer?
- What is the association of intervention on physical activity and motor performance of children aged 3-6 years?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer diagnosis at the age of 3 to 6 years
排除标准
- •No heart disease or neurological condition prohibiting physical activity -
结局指标
主要结局
Amount of child's daily physical activity is measured by parents reporting to their mobile EMPOWER user interface.
时间窗: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
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.
Age-appropriate motor skills are measured by Movement ABC measuring system
时间窗: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
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.
Quality of life of the child is measured by internationally validated Pedatric Quality of Life Inventory (PedsQoL)
时间窗: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Quality of life of the child is measured by using age-appropriate Generic Core scales of PedsQoL parent proxy forms.
Fibion SENS device is used for continuous measuring of the child's activity over 7 days.
时间窗: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Fibion SENS activity measurement is performed ovet 7 days all together three times during the whole intervention.
Feasibility of using the mobile EMPOWER application is explored by interviewing the parents/caregivers
时间窗: From enrollment to a maximum of 12 months of intervention (depending on the cancer diagnosis).
Parents/caregivers of the participating children are interviewed three times during the study period using semi-structured method developed by the study team.
次要结局
未报告次要终点