Clinical trial NCT06813950: Impact of a Physical Activity Program on the Health-Related Quality of Life in Pediatric Cancer Patients
Official title: IMPACT of a PHYSICAL ACTIVITY PROGRAM on the HEALTH-RELATED QUALITY of LIFE in PEDIATRIC CANCER PATIENTS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Pediatric Cancer
Keywords: physical activity
Quality of life
physical activity programs
lifestyle
Lead sponsor: Sociedad de Lucha Contra el Cáncer
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 80
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 1. Age range: Participants must be between 8 and 18 years old at the start of the study.

  2. 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.

  2. 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.

  6. 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.

Primary outcomes:
measure: Health related quality of life
timeFrame: 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
Secondary outcomes:
measure: Physical activity
timeFrame: surveys at baseline (week 1), midpoint (week 12), and endpoint (week 24).
Other outcomes:
Locations:
city: Quito
country: Ecuador
facility: SociedadLuchaContraCáncer
state: Pichincha
Study officials:
affiliation: Sociedad de Lucha Contra el Cáncer
name: Gustavo Galárraga, MPH
role: PRINCIPAL_INVESTIGATOR
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