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

Официальное название

IMPACT of a PHYSICAL ACTIVITY PROGRAM on the HEALTH-RELATED QUALITY of LIFE in PEDIATRIC CANCER PATIENTS

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Physical activity
  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.

Первичные конечные точки

• Health related quality of life [Срок оценки: 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]

Вторичные конечные точки (1)

• Physical activity [Срок оценки: surveys at baseline (week 1), midpoint (week 12), and endpoint (week 24).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Ecuador · 1 центр

• SociedadLuchaContraCáncer — Quito

Публикации

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• Segura-Diaz JM, Barranco-Ruiz Y, Saucedo-Araujo RG, Aranda-Balboa MJ, Cadenas-Sanchez C, Migueles JH, Saint-Maurice PF, Ortega FB, Welk GJ, Herrador-Colmenero M, Chillon P, Villa-Gonzalez E. Feasibility and reliability of the Spanish version of the Youth Activity Profile questionnaire (YAP-Spain) in children and adolescents. J Sports Sci. 2021 Apr;39(7):801-807. doi: 10.1080/02640414.2020.1847488. PMID 33213295
• Saint-Maurice PF, Welk GJ. Validity and Calibration of the Youth Activity Profile. PLoS One. 2015 Dec 2;10(12):e0143949. doi: 10.1371/journal.pone.0143949. eCollection 2015. PMID 26630346
• de Onis M, Onyango AW, Borghi E, Siyam A, Nishida C, Siekmann J. Development of a WHO growth reference for school-aged children and adolescents. Bull World Health Organ. 2007 Sep;85(9):660-7. doi: 10.2471/blt.07.043497. PMID 18026621
• Riedl D, Licht T, Nickels A, Rothmund M, Rumpold G, Holzner B, Grote V, Fischer MJ, Fischmeister G. Large Improvements in Health-Related Quality of Life and Physical Fitness during Multidisciplinary Inpatient Rehabilitation for Pediatric Cancer Survivors. Cancers (Basel). 2022 Oct 4;14(19):4855. doi: 10.3390/cancers14194855. PMID 36230777
• Keats MR, Culos-Reed SN. A community-based physical activity program for adolescents with cancer (project TREK): program feasibility and preliminary findings. J Pediatr Hematol Oncol. 2008 Apr;30(4):272-80. doi: 10.1097/MPH.0b013e318162c476. PMID 18391695
• Gotte M, Taraks S, Boos J. Sports in pediatric oncology: the role(s) of physical activity for children with cancer. J Pediatr Hematol Oncol. 2014 Mar;36(2):85-90. doi: 10.1097/MPH.0000000000000101. PMID 24390449
• Rapti C, Dinas PC, Chryssanthopoulos C, Mila A, Philippou A. Effects of Exercise and Physical Activity Levels on Childhood Cancer: An Umbrella Review. Healthcare (Basel). 2023 Mar 10;11(6):820. doi: 10.3390/healthcare11060820. PMID 36981477

Идентификаторы

NCT: NCT06813950 · 2024-068M

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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