Wearable Technology-Supported Exercise Program for Fatigue and Quality of Life in Pediatric Cancer Patients (WE-EX PedsCa)
WE-EX PedsCa
Effect of a Wearable Technology-Supported Exercise Program on Fatigue and Health-Related Quality of Life in Pediatric Cancer Patients: A Randomized Controlled Trial
1 other identifier
interventional
50
0 countries
N/A
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2026
CompletedFirst Posted
Study publicly available on registry
January 13, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedJanuary 13, 2026
January 1, 2026
1 month
January 4, 2026
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)
Secondary Outcomes (1)
Health-Related Quality of Life
Baseline (week 0), mid-intervention (week 4), and post-intervention (week 8)
Other Outcomes (1)
Exercise Adherence
Throughout the 8-week intervention period
Study Arms (2)
Wearable Technology-Supported Exercise Program
EXPERIMENTALA 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 COMPARATORParticipants 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.
Interventions
Usual pediatric oncology care with passive wearable monitoring and no structured exercise guidance.
Wearable Technology-Supported Exercise Program
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study. Due to the nature of the exercise intervention, participants and study personnel are aware of group assignment. Treating pediatric oncologists are not informed of allocation and are not involved in outcome assessments.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 4, 2026
First Posted
January 13, 2026
Study Start
March 1, 2026
Primary Completion
April 1, 2026
Study Completion
May 1, 2026
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 6 months after publication and ending 5 years following publication.
- Access Criteria
- Researchers who provide a methodologically sound proposal may request access to the data. Requests will be reviewed by the principal investigator. Data will be shared in a de-identified format to protect participant confidentiality.
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.