NCT04956133招募中不适用
Effectiveness and Implementation of Physical Activity for Children and Adolescents on Treatment for Cancer And/or Blood Diseases
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Reach
研究概览
简要总结
Physical activity can enhance well-being among youth diagnosed with oncological or hematological diseases. We developed a tailored, 1:1, online physical activity program (i.e., IMPACT), to promote physical activity in this cohort. The proposed single-group, mixed-methods project will assess the effect of IMPACT and explore markers of implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children or adolescents between the ages of 5-18 years at enrollment and at least one parent (defined as a caregiver; biological or otherwise)
- •Diagnosed with any oncological and/or hematological diagnosis
- •Currently receiving or scheduled to receive any treatment for any oncological and/or hematological diagnosis or completed treatment <3 months
排除标准
- •Completed all treatment for their oncological or hematological diagnosis >3 months
- •Unable to participate in physical activity as assessed by the patients' healthcare team or physical activity specialist
- •Parent and/or patient cannot understand verbal English
- •Parent is unwilling to be present (i.e., at home, in the same room depending on participant age and functional ability) during the physical activity sessions (required to ensure safety of the child/adolescent)
结局指标
主要结局
Reach
时间窗: Through study completion, an average of 6 years.
The number of people who participate, and reasons why or why not.
次要结局
- Time to Implement and Deliver(Through study completion, an average of 6 years.)
- Attendance(Through study completion, an average of 6 years.)
- Adherence(Through study completion, an average of 6 years.)
- Self-Reported Physical Activity Behaviour(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Directly Assessed Physical Activity Behaviour(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Functional Mobility(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Lower Extremity Endurance(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Balance(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Range of Motion(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Flexibility(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Aerobic Capacity(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Cancer-Specific Quality of Life(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Health-Related Quality of Life(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Symptoms(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Cognitive Functioning(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Maintenance of Physical Activity(Baseline (week 0), post-intervention (week 8-12), 6-month follow-up (week 20-24), 1 year follow-up (week 48-52))
- Physical Activity Fidelity(Through study completion, an average of 6 years.)
- Adverse Events(Through study completion, an average of 6 years.)
- Healthcare Provider and Staff Uptake(Through study completion, an average of 6 years.)
研究者
研究点 (2)
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