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

NCT07490548 | Enrolling By Invitation

• 1 other identifier: C-UEES-25-27
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Childhood Cancer Survivors

Keywords

lifestyle medicine; quality of life; mental health; health-related quality of life

Outcome Measures

Primary Outcomes (4)

• Health-Related Quality of Life (HRQoL)

  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.

  Baseline and 6 months

• Mental Wellbeing - Depressive Symptoms

  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)

  Baseline and 6 months

• Mental Wellbeing - Anxiety Symptoms

  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).

  Baseline and 6 months

• Lifestyle Medicine Adherence - Overall

  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).

  Baseline and 6 months

Secondary Outcomes (8)

• Adherence to Optimal Nutrition

  Baseline and 6 months

• Diet Quality

  Baseline and 6 months

• Body Mass Index (BMI)

  Baseline and 6 months.

• Adherence to Physical Activity Guidelines

  Baseline and 6 months.

• Adherence to Sleep Guidelines

  Baseline and 6 months.

Study Arms (1)

Children and adolescent aged 3 and ˂18 years who have currently finished active cancer treatment

A multicenter cohort study with a 6-month follow-up will be performed to obtain information about the adherence to the six lifestyle medicine pillars (restorative sleep, stress management, adequate nutrition, optimal physical activity, avoidance of harmful substances, and healthy social relationship), HRQoL, and mental wellbeing (anxiety and depression symptoms) among children and adolescents who finished active cancer treatment in Ecuador. Data will be collected through phone call / video call interviews or by online surveys, depending on each parent/caregiver preference. Interviewers will read questions verbatim) to reduce bias. Follow-up will be established 6 months from the first evaluation.

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescent aged 3 and ˂18 years diagnosed with cancer by imaging, cytology, or pathology who have currently finished active cancer treatment (chemotherapy, radiotherapy, surgery).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead

Study Sites (4)

SOLCA Cuenca

Cuenca, Ecuador

Location

SOLCA Guayaquil

Guayaquil, Ecuador

Location

Hospital Baca Ortiz

Quito, Ecuador

Location

Hospital SOLCA Quito

Quito, Ecuador

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• José Francisco López-Gil, PhD

  Universidad de Especialidades Espíritu Santo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Reasearcher

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

EC (4)