NCT07490548Enrolling by invitation
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 · Last updated 1 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 62 (estimated)
- First submitted
- 18 Mar 2026
- Start date
- 1 May 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Universidad de Especialidades Espiritu Santo
- Diseases
- Childhood cancers
- NCT number
- NCT07490548
What you commit to
- Study type: Observational
- Planned participants: 62
- From 1 May 2025 to the primary completion date, 30 Apr 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Individuals who suffer critical conditions (i.e., disease relapse, severe neutropenia, treatment toxicities, psychological disturbances, etc.) at the time of the recruitment.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 3 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SOLCA Cuenca Coordinator of this site? Confirm its status | Cuenca | Ecuador | Unknown status |
| SOLCA Guayaquil Coordinator of this site? Confirm its status | Guayaquil | Ecuador | Unknown status |
| Hospital SOLCA Quito Coordinator of this site? Confirm its status | Quito | Ecuador | Unknown status |
| Hospital Baca Ortiz Coordinator of this site? Confirm its status | Quito | Ecuador | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.