Pediatric CancerWE-EX PedsCaNCT07337681
Wearable Technology-Supported Exercise Program for Fatigue and Quality of Life in Pediatric Cancer Patients (WE-EX PedsCa)
A study testing standart care and Wearable Technology-Supported Exercise Program in people with Pediatric Cancer and Cancer-related Fatigue, run by Istanbul University.
Trial summary
Children and adolescents receiving cancer treatment often experience fatigue, reduced physical activity, and decreased quality of life. Although exercise has been shown to reduce these problems, maintaining regular and safe physical activity during cancer treatment can be difficult due to treatment side effects… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Pediatric Cancer, Cancer-related Fatigue, Quality of Life
- What is being tested?
- standart care and Wearable Technology-Supported Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to May 2026
- Phase
- Interventional
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 13 to 18 years.
- Diagnosed with cancer and followed at a pediatric hematology-oncology clinic.
- Currently receiving active cancer treatment and has completed at least one cycle of chemotherapy.
- Clinically stable and medically cleared by the treating physician to participate in low-to-moderate intensity exercise.
- Able to understand instructions and communicate verbally.
- Willing to participate in at least 75% of the prescribed exercise sessions.
- Written informed consent obtained from a parent or legal guardian and assent obtained from the participant.
Who cannot join
- Presence of acute infection, uncontrolled cardiac or pulmonary disease, respiratory failure, or uncontrolled hypertension.
- Severe neurological, psychiatric, or musculoskeletal conditions that limit safe participation in exercise.
- Persistent thrombocytopenia (<10,000/µL) or known coagulation disorders.
- Uncontrolled seizure disorders.
- Central nervous system metastases.
- Any medical or psychological condition deemed by the treating physician to contraindicate exercise participation or compromise study procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
rejin kebudi, professor contact
About this study
Official title: Effect of a Wearable Technology-Supported Exercise Program on Fatigue and Health-Related Quality of Life in Pediatric Cancer Patients: A Randomized Controlled Trial
Children and adolescents receiving cancer treatment often experience fatigue, reduced physical activity, and decreased quality of life. Although exercise has been shown to reduce these problems, maintaining regular and safe physical activity during cancer treatment can be difficult due to treatment side effects, safety concerns, and limited access to supervised programs.
This study aims to evaluate the feasibility, safety, and effectiveness of a wearable technology-supported exercise program on fatigue and health-related quality of life in pediatric cancer patients aged 13 to 18 years. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in an 8-week structured exercise program delivered through a mobile application, including video-guided exercise sessions performed three times per week and monitored continuously using a wearable activity tracker. The control group will receive standard care and will wear the activity tracker for passive monitoring only.
Fatigue and quality of life will be assessed at baseline, mid-intervention, and after completion of the program. Physical activity, heart rate, sleep patterns, and adherence to the exercise program will be objectively monitored using wearable devices. The findings from this study are expected to provide evidence on whether a digitally delivered, wearable-supported exercise program is a feasible and beneficial approach to improving well-being in children and adolescents undergoing cancer treatment.
Read the detailed description
Detailed Description
This study is a single-center, parallel-group, randomized controlled trial designed to evaluate the feasibility, safety, and efficacy of a wearable technology-supported structured exercise program on fatigue and health-related quality of life (HRQoL) in pediatric cancer patients aged 13-18 years who are receiving active cancer treatment.
Eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group using stratified randomization based on age, sex, and cancer diagnosis. Allocation concealment will be ensured through a secure electronic randomization system. Treating pediatric oncologists will remain blinded to group allocation.
Study Intervention
Participants in the intervention group will take part in an 8-week structured exercise program delivered through a mobile application. The program consists of video-guided exercise sessions performed three times per week, with each session lasting approximately 40 minutes. The exercise protocol includes warm-up, aerobic, strengthening, coordination, and cool-down components and is designed to be low to moderate intensity, adaptable to individual clinical conditions, and safely performed either in seated or standing positions. Exercise content was developed by a multidisciplinary team and incorporates engagement strategies such as animated guidance and gamification elements to support adherence.
Participants in the control group will receive standard care without a structured exercise intervention. Both groups will wear a commercially available wearable activity tracker throughout the study period to allow objective monitoring of physical activity and physiological parameters. In the control group, the device will be used for passive monitoring only.
Monitoring and Assessments
Fatigue and health-related quality of life will be assessed at baseline (week 0), mid-intervention (week 4), and post-intervention (week 8) using validated, age-appropriate instruments administered through the mobile platform. Objective physical activity data, including daily step counts, active minutes, heart rate, sleep duration and patterns, and device wear time, will be continuously collected via wearable devices and securely integrated into the study database.
Functional exercise capacity will be assessed using the 6-minute walk test at the same three time points. Engagement and adherence to the intervention will be evaluated using app-based metrics such as exercise session completion, frequency of use, and participation consistency.
Safety and Feasibility
Participants will be monitored throughout the study for adverse events related to exercise participation. A pediatric hematology-oncology physician and specialist nurse will oversee clinical safety. Feasibility outcomes will include recruitment rate, retention rate, adherence to exercise sessions, and completeness of wearable-derived data.
Data Analysis
Analyses will be conducted according to the intention-to-treat principle. Changes in fatigue and HRQoL over time and between groups will be examined using appropriate repeated-measures statistical methods based on data distribution. Secondary analyses will explore changes in physical activity, sleep parameters, and engagement metrics. Effect sizes will be calculated to inform the design of future multicenter trials.
Study Purpose
This trial aims to generate preliminary evidence on the clinical applicability of integrating wearable technology-supported exercise into pediatric oncology care. The findings are intended to inform larger-scale studies and contribute to the development of scalable, evidence-based digital exercise interventions for children and adolescents undergoing cancer treatment.
- Conditions
- Pediatric Cancer, Cancer-related Fatigue, Quality of Life, Exercise
- Being tested
- standart care, Wearable Technology-Supported Exercise Program
- Keywords
- Pediatric oncology, adolescent cancer, wearable technology, exercise intervention, physical activity, cancer-related fatigue, health-related quality of life, mobile health, digital exercise program
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standart careOther
Usual pediatric oncology care with passive wearable monitoring and no structured exercise guidance.
Wearable Technology-Supported Exercise ProgramOther
Wearable Technology-Supported Exercise Program
| Study group | Role | What they receive |
|---|---|---|
| Wearable Technology-Supported Exercise Program | Experimental | A structured, video-guided exercise program delivered via a mobile application and supported by continuous monitoring using a wearable activity tracker. Receives: Other: Wearable Technology-Supported Exercise Program |
| Standard Care with Passive Monitoring | Active comparator | Participants assigned to this arm will receive standard pediatric oncology care without a structured exercise program. Participants will wear a wearable activity tracker for passive monitoring of physical activity, heart rate, and sleep patterns only. Receives: Other: standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer-Related Fatigue
Cancer-related fatigue will be assessed using a validated multidimensional fatigue scale including physical, cognitive, and general fatigue subscales. Higher scores indicate greater fatigue severity.
Measured: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)
Secondary outcomes (1)
Health-Related Quality of Life
Health-related quality of life will be measured using the Pediatric Quality of Life Inventory (PedsQL 4.0) Cancer Module, which assesses physical, emotional, social, and school functioning.
Measured: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, parallel-group randomized controlled trial in which participants are assigned in a 1:1 ratio to either an intervention group receiving a wearable technology-supported structured exercise program or a control group receiving standard care with passive monitoring. Outcomes are assessed concurrently in both groups over an 8-week study period.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yagmur Berktas, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337681
- Sponsor's protocol ID
- IU-PHO-EX-2026
- Acronym
- WE-EX PedsCa
- Status last verified
- Jan 2026
- First submitted
- 4 Jan 2026
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in this study will be shared upon reasonable request. Data will be shared only after publication of the main study results and following approval of a data-sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Wearable Technology-Supported Exercise Program on Fatigue and Health-Related Quality of Life in Pediatric Cancer Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07337681
- Acronym / sponsor ID
- WE-EX PedsCa / IU-PHO-EX-2026
- Conditions
- Pediatric Cancer, Cancer-related Fatigue, Quality of Life, Exercise
- Keywords
- Pediatric oncology, adolescent cancer, wearable technology, exercise intervention, physical activity, cancer-related fatigue, health-related quality of life, mobile health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 13 Jan 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.
Children and adolescents receiving cancer treatment often experience fatigue, reduced physical activity, and decreased quality of life. Although exercise has been shown to reduce these problems, maintaining regular and safe physical activity during cancer treatment can be difficult due to treatment side effects, safety concerns, and limited access to supervised programs.
This study aims to evaluate the feasibility, safety, and effectiveness of a wearable technology-supported exercise program on fatigue and health-related quality of life in pediatric cancer patients aged 13 to 18 years. Participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in an 8-week structured exercise program delivered through a mobile application, including video-guided exercise sessions performed three times per week and monitored continuously using a wearable activity tracker. The control group will receive standard care and will wear the activity tracker for passive monitoring only.
Fatigue and quality of life will be assessed at baseline, mid-intervention, and after completion of the program. Physical activity, heart rate, sleep patterns, and adherence to the exercise program will be objectively monitored using wearable devices. The findings from this study are expected to provide evidence on whether a digitally delivered, wearable-supported exercise program is a feasible and beneficial approach to improving well-being in children and adolescents undergoing cancer treatment.
Detailed description
Detailed Description
This study is a single-center, parallel-group, randomized controlled trial designed to evaluate the feasibility, safety, and efficacy of a wearable technology-supported structured exercise program on fatigue and health-related quality of life (HRQoL) in pediatric cancer patients aged 13-18 years who are receiving active cancer treatment.
Eligible participants will be randomly assigned in a 1:1 ratio to either an intervention group or a control group using stratified randomization based on age, sex, and cancer diagnosis. Allocation concealment will be ensured through a secure electronic randomization system. Treating pediatric oncologists will remain blinded to group allocation.
Study Intervention
Participants in the intervention group will take part in an 8-week structured exercise program delivered through a mobile application. The program consists of video-guided exercise sessions performed three times per week, with each session lasting approximately 40 minutes. The exercise protocol includes warm-up, aerobic, strengthening, coordination, and cool-down components and is designed to be low to moderate intensity, adaptable to individual clinical conditions, and safely performed either in seated or standing positions. Exercise content was developed by a multidisciplinary team and incorporates engagement strategies such as animated guidance and gamification elements to support adherence.
Participants in the control group will receive standard care without a structured exercise intervention. Both groups will wear a commercially available wearable activity tracker throughout the study period to allow objective monitoring of physical activity and physiological parameters. In the control group, the device will be used for passive monitoring only.
Monitoring and Assessments
Fatigue and health-related quality of life will be assessed at baseline (week 0), mid-intervention (week 4), and post-intervention (week 8) using validated, age-appropriate instruments administered through the mobile platform. Objective physical activity data, including daily step counts, active minutes, heart rate, sleep duration and patterns, and device wear time, will be continuously collected via wearable devices and securely integrated into the study database.
Functional exercise capacity will be assessed using the 6-minute walk test at the same three time points. Engagement and adherence to the intervention will be evaluated using app-based metrics such as exercise session completion, frequency of use, and participation consistency.
Safety and Feasibility
Participants will be monitored throughout the study for adverse events related to exercise participation. A pediatric hematology-oncology physician and specialist nurse will oversee clinical safety. Feasibility outcomes will include recruitment rate, retention rate, adherence to exercise sessions, and completeness of wearable-derived data.
Data Analysis
Analyses will be conducted according to the intention-to-treat principle. Changes in fatigue and HRQoL over time and between groups will be examined using appropriate repeated-measures statistical methods based on data distribution. Secondary analyses will explore changes in physical activity, sleep parameters, and engagement metrics. Effect sizes will be calculated to inform the design of future multicenter trials.
Study Purpose
This trial aims to generate preliminary evidence on the clinical applicability of integrating wearable technology-supported exercise into pediatric oncology care. The findings are intended to inform larger-scale studies and contribute to the development of scalable, evidence-based digital exercise interventions for children and adolescents undergoing cancer treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, parallel-group randomized controlled trial in which participants are assigned in a 1:1 ratio to either an intervention group receiving a wearable technology-supported structured exercise program or a control group receiving standard care with passive monitoring. Outcomes are assessed concurrently in both groups over an 8-week study period.
| Arm | Type | Receives |
|---|---|---|
| Wearable Technology-Supported Exercise Program | Experimental | Other: Wearable Technology-Supported Exercise ProgramA structured, video-guided exercise program delivered via a mobile application and supported by continuous monitoring using a wearable activity tracker. |
| Standard Care with Passive Monitoring | Active comparator | Other: standart careParticipants assigned to this arm will receive standard pediatric oncology care without a structured exercise program. Participants will wear a wearable activity tracker for passive monitoring of physical activity, heart rate, and sleep patterns only. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged 13 to 18 years.
- Diagnosed with cancer and followed at a pediatric hematology-oncology clinic.
- Currently receiving active cancer treatment and has completed at least one cycle of chemotherapy.
- Clinically stable and medically cleared by the treating physician to participate in low-to-moderate intensity exercise.
- Able to understand instructions and communicate verbally.
Key exclusion criteria (6 listed)
- Presence of acute infection, uncontrolled cardiac or pulmonary disease, respiratory failure, or uncontrolled hypertension.
- Severe neurological, psychiatric, or musculoskeletal conditions that limit safe participation in exercise.
- Persistent thrombocytopenia (<10,000/µL) or known coagulation disorders.
- Uncontrolled seizure disorders.
- Central nervous system metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standart careUsual pediatric oncology care with passive wearable monitoring and no structured exercise guidance. | Other | Standard Care with Passive Monitoring |
| Wearable Technology-Supported Exercise ProgramWearable Technology-Supported Exercise Program | Other | Wearable Technology-Supported Exercise Program |
Primary outcome
Cancer-Related Fatigue
Time frame: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)
Cancer-related fatigue will be assessed using a validated multidimensional fatigue scale including physical, cognitive, and general fatigue subscales. Higher scores indicate greater fatigue severity.
1 secondary outcome
Health-Related Quality of Life
Time frame: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)
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 13 Jan 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in this study will be shared upon reasonable request. Data will be shared only after publication of the main study results and following approval of a data-sharing request.
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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.
rejin kebudi, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing standart care and Wearable Technology-Supported Exercise Program in people with Pediatric Cancer and Cancer-related Fatigue, run by Istanbul University.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yagmur Berktas, phd candidate (+90 5442753844, yagmurberktas07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cancer-Related Fatigue (time frame: Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)). 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 13 Jan 2026.