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

NCT06813950 | Not Yet Recruiting

• 1 other identifier: 2024-068M
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Pediatric Cancer

Keywords

physical activity; Quality of life; physical activity programs; lifestyle

Outcome Measures

Primary Outcomes (1)

• Health related quality of life

  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?".

  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 (1)

• Physical activity

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

Study Arms (1)

Physical activity

OTHER

Performs supervised physical activity

Other: Physical activity

Interventions

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.

Physical activity

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Sociedad de Lucha Contra el Cáncer: lead

Study Sites (1)

SociedadLuchaContraCáncer

Quito, Pichincha, 170138, Ecuador

Location

Related Publications (16)

• Varni JW, Burwinkle TM, Katz ER, Meeske K, Dickinson P. The PedsQL in pediatric cancer: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module. Cancer. 2002 Apr 1;94(7):2090-106. doi: 10.1002/cncr.10428.

  PMID: 11932914 BACKGROUND

• 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. Epub 2020 Nov 20.

  PMID: 33213295 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Chaput JP, Willumsen J, Bull F, Chou R, Ekelund U, Firth J, Jago R, Ortega FB, Katzmarzyk PT. 2020 WHO guidelines on physical activity and sedentary behaviour for children and adolescents aged 5-17 years: summary of the evidence. Int J Behav Nutr Phys Act. 2020 Nov 26;17(1):141. doi: 10.1186/s12966-020-01037-z.

  PMID: 33239009 BACKGROUND

• Zhang FF, Saltzman E, Must A, Parsons SK. Do Childhood Cancer Survivors Meet the Diet and Physical Activity Guidelines? A Review of Guidelines and Literature. Int J Child Health Nutr. 2012;1(1):44-58. doi: 10.6000/1929-4247.2012.01.01.06. Epub 2012 Sep 25.

  PMID: 26973721 BACKGROUND

• Braam KI, van der Torre P, Takken T, Veening MA, van Dulmen-den Broeder E, Kaspers GJ. Physical exercise training interventions for children and young adults during and after treatment for childhood cancer. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD008796. doi: 10.1002/14651858.CD008796.pub2.

  PMID: 23633361 BACKGROUND

• Oficina Regional para las Américas de la Organización Mundial de la Salud. https://www.paho.org/es/temas/cancer-ninez-adolescencia#:~:text=En%20Am%C3%A9rica%20Latina%20y%20el,a%20causa%20de%20esta%20enfermedad. 2014 [cited 2024 Dec 1]. EL CÁNCER INFANTIL EN LAS AMÉRICAS. Available from: https://www.paho.org/es/temas/cancer-ninez-adolescencia#:~:text=En%20Am%C3%A9rica%20Latina%20y%20el,a%20causa%20de%20esta%20enfermedad

  BACKGROUND

• San Juan AF, Chamorro-Vina C, Mate-Munoz JL, Fernandez del Valle M, Cardona C, Hernandez M, Madero L, Perez M, Ramirez M, Lucia A. Functional capacity of children with leukemia. Int J Sports Med. 2008 Feb;29(2):163-7. doi: 10.1055/s-2007-964908. Epub 2007 Sep 18.

  PMID: 17879894 BACKGROUND

• Tillmann V, Darlington AS, Eiser C, Bishop NJ, Davies HA. Male sex and low physical activity are associated with reduced spine bone mineral density in survivors of childhood acute lymphoblastic leukemia. J Bone Miner Res. 2002 Jun;17(6):1073-80. doi: 10.1359/jbmr.2002.17.6.1073.

  PMID: 12054163 BACKGROUND

• 3. INEC. Juntos para combatir el sedentarismo mediante el deporte y la actividad física. 2022. Juntos para combatir el sedentarismo mediante el deporte y la actividad física.

  BACKGROUND

• Wurz A, McLaughlin E, Lategan C, Chamorro Vina C, Grimshaw SL, Hamari L, Gotte M, Kesting S, Rossi F, van der Torre P, Guilcher GMT, McIntyre K, Culos-Reed SN. The international Pediatric Oncology Exercise Guidelines (iPOEG). Transl Behav Med. 2021 Oct 23;11(10):1915-1922. doi: 10.1093/tbm/ibab028.

  PMID: 34037786 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Gustavo Galárraga, MPH

  Sociedad de Lucha Contra el Cáncer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gustavo Galárraga, MPH

CONTACT

0991946128; gustavo.galarraga@solcaquito.org.ec

Yunqi Yu, MPH

CONTACT

+19142073580; yu.yunqi@solcaquito.org.ec

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Analyst Investigation Department

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 7, 2025
• Study Start: February 20, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)