Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Childhood Cancer Survivors. Basic parameters: 3 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ecuador
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador: Protocol for a Multicenter Study
Overview
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.
Primary outcome measures
- Health-Related Quality of Life (HRQoL) [Time frame: Baseline and 6 months]
- Mental Wellbeing - Depressive Symptoms [Time frame: Baseline and 6 months]
- Mental Wellbeing - Anxiety Symptoms [Time frame: Baseline and 6 months]
- Lifestyle Medicine Adherence - Overall [Time frame: Baseline and 6 months]
Secondary outcome measures (8)
- Adherence to Optimal Nutrition [Time frame: Baseline and 6 months]
- Diet Quality [Time frame: Baseline and 6 months]
- Body Mass Index (BMI) [Time frame: Baseline and 6 months.]
- Adherence to Physical Activity Guidelines [Time frame: Baseline and 6 months.]
- Adherence to Sleep Guidelines [Time frame: Baseline and 6 months.]
- Social Connections [Time frame: Baseline and 6 months.]
- Stress Management [Time frame: Baseline and 6 months.]
- Avoidance of Harmful Substances [Time frame: Baseline and 6 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ecuador · 4 centers
- SOLCA Cuenca — Cuenca
- SOLCA Guayaquil — Guayaquil
- Hospital Baca Ortiz — Quito
- Hospital SOLCA Quito — Quito
Identifiers
NCT: NCT07490548 · C-UEES-25-27