Clinical Trial

Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador

Enrolling by Invitation
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Summary
Background: Advances in pediatric oncology have significantly improved survival rates; however, many children and adolescents with cancer experience persistent physical and psychological challenges that negatively affect their health-related quality of life (HRQoL). Lifestyle medicine (comprising regular physical activity, restorative sleep, optimal nutrition, stress management, avoidance of risky substances, and positive social connections) is increasingly recognized as a determinant of well-being in chronic disease populations. However, evidence on its role in pediatric oncology survivorship remains limited, particularly in low- and middle-income countries like Ecuador. Methods: A multicenter cohort study with a 6-month follow-up will evaluate the association between adherence to lifestyle medicine pillars and HRQoL among children and adolescents who have completed active cancer treatment in Ecuador. A total of 57-62 participants aged 3 to \<18 years receiving care in major pediatric oncology centers will be recruited. The adherence to the 6 pillars of lifestyle medicine will be assessed using validated questionnaires. HRQoL will be measured using the Pediatric Quality of Life Inventory (PedsQL), while mental health outcomes will be evaluated through validated PROMIS measures. Sociodemographic and clinical variables will also be collected. Cross-sectional and longitudinal generalized linear mixed models will be used to explore associations between lifestyle behaviors, mental health, and HRQoL, adjusting for relevant confounders. Conclusion: This study will provide one of the first comprehensive assessments of the prevalence, time trends, and associated factors of lifestyle medicine adherence and its relationship with quality of life and mental health among pediatric oncology patients in Ecuador. Results may help identify modifiable lifestyle factors associated with better wellbeing and inform future supportive care strategies and lifestyle-based interventions for children and adolescents with cancer.
Protocol Amendment History 2 changes
critical Primary endpoint(s) modified 2026-04-02
critical Primary endpoint(s) modified 2026-03-27
Trial Details
NCT Number NCT07490548
Lead Sponsor Universidad de Especialidades Espiritu Santo
Conditions Childhood Cancer Survivors
Enrollment 62 participants
Start Date 2025-05-01
Primary Completion 2027-04-30 (estimated)
Study Completion 2027-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-01