Clinical trial · Observational
Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador
Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador: Protocol for a Multicenter Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Childhood Cancer Survivors | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Children and adolescent aged 3 and ˂18 years who have currently finished active cancer treatment
- description
- A multicenter cohort study with a 6-month follow-up will be performed to obtain information about the adherence to the six lifestyle medicine pillars (restorative sleep, stress management, adequate nutrition, optimal physical activity, avoidance of harmful substances, and healthy social relationship), HRQoL, and mental wellbeing (anxiety and depression symptoms) among children and adolescents who finished active cancer treatment in Ecuador. Data will be collected through phone call / video call interviews or by online surveys, depending on each parent/caregiver preference. Interviewers will read questions verbatim) to reduce bias. Follow-up will be established 6 months from the first evaluation.
Primary outcomes (4)
- measure
- Health-Related Quality of Life (HRQoL)
- timeFrame
- Baseline and 6 months
- description
- Assessed using the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and PedsQL 3.0 Cancer Module. A higher score indicates better HRQoL. Unit of Measure: Score on a scale from 0 to 100.
- measure
- Mental Wellbeing - Depressive Symptoms
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Children and adolescent aged 3 and ˂18 years. * Participants diagnosed with cancer by imaging, cytology, or pathology who have currently finished active cancer treatment (chemotherapy, radiotherapy, surgery). * Individuals attending medical consultations follow-up at one of the oncology centers from the study. Exclusion Criteria: * Individuals who suffer critical conditions (i.e., disease relapse, severe neutropenia, treatment toxicities, psychological disturbances, etc.) at the time of the recruitment. * Participants who are not authorized by the parents or legal guardians to participate in the research project. * Participants who do not agree to take part in the research project.
References
Publications (0)
Data not yet available