IMPACT of a PHYSICAL ACTIVITY PROGRAM on the HEALTH-RELATED QUALITY of LIFE in PEDIATRIC CANCER PATIENTS
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Health related quality of life
研究概览
简要总结
Physical activity is essential for the health and well-being of children and adolescents. However, those living with cancer often experience reduced physical activity levels, which negatively impact their functional capacity and health-related quality of life (HRQoL). In Ecuador, data from the National Institute of Statistics and Census (2021) reveal that 20% of children engage in less than one hour of physical activity per week, highlighting the need for targeted interventions. While previous studies demonstrate that supervised exercise programs can improve physical and psychosocial health outcomes in pediatric oncology patients, no evidence exists from Ecuador to assess the effects of such programs.
This study will examine the impact of a structured physical activity program on the HRQoLof pediatric cancer patients in Quito, Ecuador. Using a case-control design, 90 participants will be randomized into two groups: an intervention group receiving a 10-week, supervised physical activity program and a control group with no exercise intervention and the programmed usual care as follow up if needed by the social worker. HRQoL surveys using a standardized instrument will be administered to all participants (those in the intervention group and those in the control group) at weeks 1, 12, and 24 to assess changes over time.
This research will address a critical public health gap by exploring how physical activity can mitigate the adverse effects of cancer treatment, improve physical and emotional health, and enhance the HRQoL in pediatric oncology patients. Findings will contribute valuable insights for integrating physical activity into pediatric oncology care in low- and middle-income countries.
详细描述
This study is designed as a randomized controlled trial (RCT) to investigate the impact of a structured exercise program on the HRQoL of pediatric cancer patients. A total of 90 participants will be recruited and randomly assigned to either the intervention group or the control group.
The intervention group will participate in a 10-week structured physical activity program consisting of 120 minutes of supervised exercise per week, led by a team of physiotherapists and physical activity professionals. Meanwhile, the control group will not participate in any organized physical activity program but will continue with their usual activities.
Both groups will complete the Pediatric Quality of Life Inventory (PedsQL) surveys at baseline (week 1), midpoint (week 12), and endpoint (week 24). These surveys are designed to assess changes in participants' HRQoL over time, providing comparative insights between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: Participants must be between 8 and 18 years old at the start of the study.
- •Residency: Patients residing within the city limits of Quito, Ecuador.
- •Treatment status:
- •Patients are being evaluated or treated at Hospitals SOLCA and Baca Ortiz.
- •Patients are either currently undergoing active treatment for pediatric malignancies, or
- •Patients are in the post-treatment phase after a pediatric cancer diagnosis.
- •The volunteer or a family member that lives with the possible participant has a cellphone so the survey can be administered and answered.
排除标准
- •The presence of a malignant solid tumor which has not yet been surgically addressed.
- •A psychiatric diagnosis of cognitive impairment.
- •A diagnosis of osteosarcoma.
- •A history of cardiac pathology.
- •The patient is in the pediatric inpatient ward or was one month prior to the enrollment phase.
- •The patient is stationed at the pediatric intensive care unit.
- •The patient received high-dose chemotherapy with methotrexate greater than 1000 mg/m2/dose or cytarabine greater than 1 g/m2/dose in the last month.
结局指标
主要结局
Health related quality of life
时间窗: oth groups will complete the Pediatric Quality of Life Inventory (PedsQL) surveys at baseline (week 1), midpoint (week 12), and endpoint (week 24). These surveys are designed to assess changes in participants' HRQoL over time, providing comparative insig
To evaluate HRQoL, the study will use the PedsQL, specifically the PedsQL 3.0 Cancer Module, a validated instrument for pediatric cancer patients aged 2 to 18 years. This module comprises 20 questions addressing physical, emotional, and social functioning, as well as cancer treatment-related symptoms. Participants will self-report their responses using a four-point Likert scale, with options ranging from "never" (0) to "almost always" (4). For example: "In the past month, how often have you felt tired?"; "In the past month, how often have you experienced pain or discomfort?".
次要结局
- Physical activity(surveys at baseline (week 1), midpoint (week 12), and endpoint (week 24).)
研究者
Gustavo Galarraga
Analyst Investigation Department
Sociedad de Lucha Contra el Cáncer del Ecuador