Childhood Cancer SurvivorsNCT07490548
Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador
An observational study of Childhood Cancer Survivors, run by Universidad de Especialidades Espiritu Santo at 4 sites in Ecuador.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Childhood Cancer Survivors
- How many people
- 62 participants
- Where
- 4 sitesEcuador
- Study dates
- 1 May 2025to 30 Apr 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ecuador4 sites
SOLCA Cuenca
Cuenca
SOLCA Guayaquil
Guayaquil
Hospital Baca Ortiz
Quito
Hospital SOLCA Quito
Quito
About this study
Official title: Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador: Protocol for a Multicenter Study
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
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Baseline and 6 months
Secondary outcomes (8)
Adherence to Optimal Nutrition
Assessed using the KIDMED (Mediterranean Diet Quality Index) questionnaire. A higher score indicates better adherence to a Mediterranean diet.
Measured: Baseline and 6 months
Diet Quality
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.
Measured: Baseline and 6 months
Body Mass Index (BMI)
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
Measured: Baseline and 6 months.
Adherence to Physical Activity Guidelines
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).
Measured: Baseline and 6 months.
Adherence to Sleep Guidelines
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).
Measured: Baseline and 6 months.
Social Connections
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).
Measured: Baseline and 6 months.
Stress Management
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).
Measured: Baseline and 6 months.
Avoidance of Harmful Substances
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.
Measured: Baseline and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 May 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Cancer SurvivorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universidad de Especialidades Espiritu Santo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José Francisco López Gil, Universidad de Especialidades Espiritu Santo
- Investigators
- José Francisco López-Gil, PhD, Principal investigator, Universidad de Especialidades Espiritu Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490548
- Sponsor's protocol ID
- C-UEES-25-27
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Medicine Adherence, Mental Wellbeing, and Quality of Life in Pediatric Oncology in Ecuador: Protocol for a Multicenter Study
- ClinicalTrials.gov ID
- NCT07490548
- Acronym / sponsor ID
- C-UEES-25-27
- Conditions
- Childhood Cancer Survivors
- Keywords
- lifestyle medicine, quality of life, mental health, health-related quality of life
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universidad de Especialidades Espiritu SantoUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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)
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).
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).
8 secondary outcomes
Adherence to Optimal Nutrition
Time frame: Baseline and 6 months
Diet Quality
Time frame: Baseline and 6 months
Body Mass Index (BMI)
Time frame: Baseline and 6 months.
Adherence to Physical Activity Guidelines
Time frame: Baseline and 6 months.
Adherence to Sleep Guidelines
Time frame: Baseline and 6 months.
Social Connections
Time frame: Baseline and 6 months.
Stress Management
Time frame: Baseline and 6 months.
Avoidance of Harmful Substances
Time frame: Baseline and 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Childhood Cancer Survivors
Recruiting
Facial Expression Awareness Training to Understand and Recognize Emotions
Survivors of Pediatric Brain Tumors, Pediatric Cancer
Not yet recruiting
Multi-level Intervention to Successfully Transition to Adult Care for Survivors of Childhood and Adolescent Cancers: The BRIDGES-YAS! Study
Health Care Transition, Survivorship Care
Recruiting
Preparing for Life and Academics for Young Childhood Cancer Survivors
Childhood Cancer
RecruitingObservational study
Feasibility and Acceptability of Remote Saliva Collection
Survivors of Childhood Cancer, Acute Lymphoblastic Leukemia, Childhood
RecruitingPhase 3
Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue
Brain Tumor, Pediatric, Cancer-related Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
José Francisco López-Gil, PhD principal investigator
Universidad de Especialidades Espiritu Santo
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cancer Survivors, run by Universidad de Especialidades Espiritu Santo at 4 sites in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (HRQoL) (time frame: Baseline and 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.