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NCT Number: NCT06813950

Impact of a Physical Activity Program on the Health-Related Quality of Life in Pediatric Cancer Patients

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.

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms Pediatric Cancer

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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. 3. 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.

Exclusion criteria

  • 1. The presence of a malignant solid tumor which has not yet been surgically addressed.
  • A psychiatric diagnosis of cognitive impairment. 3. A diagnosis of osteosarcoma. 4. A history of cardiac pathology. 5. 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. 7. 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.

Treatment and study plan

Physical activity

Other

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.

Primary outcomes

  1. Health related quality of life

    Time frame: 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?".

Secondary outcomes

  1. Physical activity

    Time frame: surveys at baseline (week 1), midpoint (week 12), and endpoint (week 24).

    Physical activity and sedentary habits will be determined using the Activity Profile - Spain - Version for Latin America. (YAP-SL), a self-report tool consisting of 15 items, will be used to gather data on physical activity levels and sedentary behaviors for a 7-day recall period

Study contacts

Contact information is provided by the study sponsor or research team.

Gustavo Galárraga, MPH

CONTACT

[email protected]

0991946128

Yunqi Yu, MPH

CONTACT

[email protected]

+19142073580

Sponsors and collaborators

Lead sponsor

Sociedad de Lucha Contra el Cáncer

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2025
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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