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Enrolling by Invitation

NCT Number: NCT07490548

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

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.

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Key information

Conditions

Childhood Cancer Survivors Behavior Personal Satisfaction Psychological Well-Being

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SOLCA Cuenca, Cuenca, Ecuador

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Health-Related Quality of Life (HRQoL)

    Time frame: Baseline and 6 months

    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.

  2. Mental Wellbeing - Depressive Symptoms

    Time frame: Baseline and 6 months

    Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Early Childhood Parent-Report Short Form v1.0, PROMIS Parent Proxy Bank v2.0, or PROMIS Pediatric Short Form GenPop v3.0, depending on participant age. A higher T-score indicates more severe symptoms.

    Unit of Measure: T-score (standardized score with a mean of 50 and standard deviation of 10)

  3. Mental Wellbeing - Anxiety Symptoms

    Time frame: Baseline and 6 months

    Assessed using the PROMIS Early Childhood Parent-Report Short Form v1.0, PROMIS Parent Proxy Short Form v2.0, or PROMIS Pediatric Short Form GenPop v3.0, depending on participant age. A higher T-score indicates more severe symptoms.

    Unit of Measure: T-score (standardized score with a mean of 50 and standard deviation of 10).

  4. Lifestyle Medicine Adherence - Overall

    Time frame: Baseline and 6 months

    For each of the six lifestyle medicine pillars (optimal nutrition, regular physical activity, restorative sleep, stress management, avoidance of harmful substances, and positive social connections), participants will be classified as meeting or not meeting the corresponding clinical or oncological guideline-based recommendations using data from the validated instruments described in the protocol. An overall binary classification (meets overall recommendations / does not meet overall recommendations) will be derived based on predefined criteria (e.g., meeting a minimum number of pillars or meeting all pillars) in accordance with supportive care guidelines for pediatric oncology survivorship.

    Unit of Measure: Binary classification (meets overall lifestyle medicine recommendations / does not meet overall recommendations).

Secondary outcomes

  1. Adherence to Optimal Nutrition

    Time frame: Baseline and 6 months

    Assessed using the KIDMED (Mediterranean Diet Quality Index) questionnaire. A higher score indicates better adherence to a Mediterranean diet.

  2. Diet Quality

    Time frame: Baseline and 6 months

    Assessed using the Diet Quality Questionnaire (DQQ) to calculate the Global Dietary Recommendations (GDR) score. A higher score indicates greater adherence to healthy dietary practices.

    Unit of Measure: Score on a scale from 0 to 18.

  3. Body Mass Index (BMI)

    Time frame: Baseline and 6 months.

    Calculated from weight and height extracted from the medical record. Weight and height will be combined to report BMI in kg/m^2.

    Unit of Measure: kg/m^2

  4. Adherence to Physical Activity Guidelines

    Time frame: Baseline and 6 months.

    Assessed using the Youth Activity Profile (YAP), the Global School-Based Student Health Survey (GSHS) Physical Activity Module, and the Questionnaire for the Measurement of Physical Activity and Sedentary Behavior in Children (C-MAFYCS) depending on the age of the participant. Meeting the World Health Organization (WHO) guidelines is defined as an average of at least 60 minutes per day of moderate-to-vigorous physical activity. Unit of Measure: Binary classification (meets guidelines / does not meet guidelines).

  5. Adherence to Sleep Guidelines

    Time frame: Baseline and 6 months.

    Sleep duration is calculated from self- or parent-reported bedtimes and wake-up times. Meeting the National Sleep Foundation guidelines is defined as the following age-appropriate sleep duration ranges: 8-10 hours for adolescents, 9-11 hours for school-age children, 10-13 hours for preschoolers, and 11-14 hours for toddlers.

    Unit of Measure: Binary classification (meets guidelines / does not meet guidelines).

  6. Social Connections

    Time frame: Baseline and 6 months.

    Assessed using the Strengths and Difficulties Questionnaire (SDQ), the Multidimensional Scale of Perceived Social Support (MSPSS) for family and friends support, and the Health Behavior in School-aged Children (HBSC) social support subscales for classmates and teachers support. These measures assess peer relationship problems, prosocial behavior, and perceived support from family, friends, teachers, and classmates.

    Unit of Measure: Score (varies by instrument).

  7. Stress Management

    Time frame: Baseline and 6 months.

    Assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Psychological Stress Experiences (Pediatric Short Form v1.0 or Parent Proxy Short Form v1.0). A higher T-score indicates a more severe psychological stress experience.

    Unit of Measure: T-score (standardized score with a mean of 50 and standard deviation of 10).

  8. Avoidance of Harmful Substances

    Time frame: Baseline and 6 months.

    Assessed through questions about secondhand smoke exposure, personal substance use (cigarettes, alcohol, cannabis, e-cigarettes), and energy drink consumption. For participants aged 11 and older, this includes the lifetime prevalence and frequency of use.

    Unit of Measure: Binary (yes/no) for exposure and use; frequency counts for personal use.

Sponsors and collaborators

Lead sponsor

Universidad de Especialidades Espiritu Santo

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 24, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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