Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador: Protocol for a Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- Prevalence, time trends, and associated factors between the adherence to the six pillars of lifestyle medicine on HRQoL and mental wellbeing
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Prevalence, time trends, and associated factors between the adherence to the six pillars of lifestyle medicine on HRQoL and mental wellbeing
时间窗: 2025-2027
To explore associations between lifestyle behaviors (restorative sleep, stress management, adequate nutrition, optimal physical activity, avoidance of harmful substances, and healthy social relationship), mental health (anxiety and depression symptoms), and HRQoL, adjusting for relevant confounders.
次要结局
未报告次要终点
研究者
José Francisco López Gil
Senior Reasearcher
Universidad de Especialidades Espiritu Santo