Dyadic-based Physical Activity Intervention for Children Who Are Undergoing Cancer Treatment: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 198
- 主要终点
- Physical Activity Level
研究概览
简要总结
The goal of this study is to learn if a parent-child dyadic physical activity (PA) intervention works to improve physical activity levels in children with leukaemia. It will also learn about the intervention's effects on children's self-confidence in doing physical activity and their quality of life. The main questions it aims to answer are:
Does the dyadic PA intervention increase the amount of physical activity children do, compared with an individual PA intervention or usual care? Does the dyadic PA intervention improve children's confidence in doing physical activity and their overall quality of life? What is the cost-effectiveness of the dyadic intervention relative to the individual intervention and psychological support control group?
Researchers will compare three groups: children and parents doing physical activity together (dyadic intervention), children doing physical activity individually (individual intervention), and children receiving psychological support sessions only (control group), to see if involving parents makes a difference.
Participants will:
Attend weekly sessions for 3 months (12 sessions total) Wear an activity tracker for 7 days and complete questionnaires at 5 different time points over 12 months Some participants will also be invited to take part in an interview about their experience
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 9-18 years old
- •Diagnosed with leukaemia
- •Currently undergoing maintenance therapy
- •Have a parent willing to participate in the study
- •Both the child and participating parent speak Cantonese and read Chinese
排除标准
- •Children under palliative care with evidence of cancer recurrence or second malignancies
- •Children with medical contraindications for PA, such as thrombosis, as documented by physicians
- •Children or parents with physical impairment or cognitive and learning problems (identified from medical records)
- •Participants in the team's other interventional studies
研究组 & 干预措施
Dyadic Intervention
Parent-child dyads complete a 3-month, 12-session physical activity program together, with intensity tailored to each child.
干预措施: Dyadic Physical Activity Intervention (Behavioral)
Control
Children receive 12 weekly sessions of simple psychological support over 3 months, without a physical activity component.
干预措施: Psychological Support (Behavioral)
Individual Intervention
Children complete the same 3-month, 12 weekly sessions physical activity program as the dyadic group, but without parental participation.
干预措施: Individual Intervention (Behavioral)
结局指标
主要结局
Physical Activity Level
时间窗: Baseline and 12 months（T4）
Children's physical activity levels will be objectively measured using ActiGraph GT3X accelerometers, worn for 7 consecutive days at each assessment timepoint. The primary outcome is the minutes engaged in moderate-to-vigorous physical activity (MVPA).
次要结局
- Self-Reported Physical Activity Level(Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4))
- Physical Activity Self-Efficacy Score(Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4))
- Health-Related Quality of Life Score (EQ-5D-Y-5L)(Baseline, 3 months (T1), 6 months (T2), 9 months (T3), and 12 months (T4))
研究者
Dr Katherine Lam
Assistant Professor
The Hong Kong Polytechnic University