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Набор по приглашению NCT07490548

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

— Наблюдательное Childhood Cancer Survivors

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Childhood Cancer Survivors. Базовые параметры: 3 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Ecuador
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador: Protocol for a Multicenter Study

Обзор

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.

Первичные конечные точки

  • Health-Related Quality of Life (HRQoL) [Срок оценки: Baseline and 6 months]
  • Mental Wellbeing - Depressive Symptoms [Срок оценки: Baseline and 6 months]
  • Mental Wellbeing - Anxiety Symptoms [Срок оценки: Baseline and 6 months]
  • Lifestyle Medicine Adherence - Overall [Срок оценки: Baseline and 6 months]
Вторичные конечные точки (8)
  • Adherence to Optimal Nutrition [Срок оценки: Baseline and 6 months]
  • Diet Quality [Срок оценки: Baseline and 6 months]
  • Body Mass Index (BMI) [Срок оценки: Baseline and 6 months.]
  • Adherence to Physical Activity Guidelines [Срок оценки: Baseline and 6 months.]
  • Adherence to Sleep Guidelines [Срок оценки: Baseline and 6 months.]
  • Social Connections [Срок оценки: Baseline and 6 months.]
  • Stress Management [Срок оценки: Baseline and 6 months.]
  • Avoidance of Harmful Substances [Срок оценки: Baseline and 6 months.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Ecuador · 4 центра
  • SOLCA Cuenca — Cuenca
  • SOLCA Guayaquil — Guayaquil
  • Hospital Baca Ortiz — Quito
  • Hospital SOLCA Quito — Quito

Идентификаторы

NCT: NCT07490548 · C-UEES-25-27

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗