CancerNCT07003607
Wearable Device and Self-Regulation Strategies to Promote Physical Activity Among Children With Cancer: A Pilot Study
A study testing In-Hospital Program and Post-Discharge Program in people with Cancer, run by Ke Liu at 1 site in China.
Trial summary
This is a clinical trial that tested whether a 12-week exercise program using smart wristbands and personalized goal-setting could help children with cancer become more active, feel more confident about exercising, and improve their quality of life. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- In-Hospital Program and Post-Discharge Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2023to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 6 and 18 years old;
- Children diagnosed with leukemia, lymphoma, or solid tumor confirmed by pathology or bone marrow examination;
- Obtaining informed consent from the child and their guardian;
- Approval from the attending physician for participation in physical activity interventions.
Who cannot join
- Children diagnosed with mental health disorders;
- Individuals with severe physical disabilities incompatible with physical activity participation;
- Cases involving metastasis to bone tissue that would restrict movement.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen University Cancer Prevention Center
Guangzhou, Guangdong, 510080
About this study
This is a clinical trial that tested whether a 12-week exercise program using smart wristbands and personalized goal-setting could help children with cancer become more active, feel more confident about exercising, and improve their quality of life.
The study included 72 children and teenagers (ages 6-18) receiving cancer treatment at two hospitals in China. They were divided into two groups:
Read more
Intervention group (33 children): Used a smart wristband to track daily steps, followed a personalized exercise plan, and received weekly guidance.
Control group (39 children): Continued with usual care (no special exercise program).
The main questions it aims to answer are:
- Does the exercise program help children with cancer move more and sit less;
- Can it boost their confidence to stay active and improve their physical and emotional well-being?
Read the detailed description
What did the study find?
- Children in the exercise group:
- Increased active time: They did more moderate-to-vigorous exercise (like brisk walking or playing) by the end of the program.
- Walked more steps daily: From about 2,200 steps/day at the start to over 6,300 steps/day after 12 weeks.
- Felt more confident: They believed they could keep exercising even during treatment.
- Improved well-being: Parents and children reported better physical energy, mood, and social interactions.
- Comparison with the control group:
- The exercise group showed much greater improvements than the group without the program.
What does this mean for families? This study suggests that combining wearable devices (like step trackers) with simple goal-setting and family support may help children with cancer stay active during treatment. Staying active could reduce fatigue, improve mood, and support recovery.
What's next? While these results are promising, larger studies are needed to confirm the long-term benefits and safety of such programs.
- Conditions
- Cancer
- Being tested
- Control group (placebo), In-Hospital Program, Post-Discharge Program
- Keywords
- physical activity, childhood cancer, quality of life, physical activity self-efficacy, Integrated theory of health behavior change
- 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.
Control group (placebo)Behavioural
Children in the control group received routine health education, which included cancer-related treatment, care, and general health education (e.g., treatment-related, diet, and exercise) without systematic PA health education. Every four weeks, knowledge related to sports activities, the harms of insufficient physical activity, and the benefits of increasing physical activity were pushed through the WeChat platform. During the hospitalization of the child patient, they can voluntarily participate in the activities organized by social workers.
In-Hospital ProgramBehavioural
Researchers will conduct a comprehensive evaluation for each pediatric patient, including:
- Disease status and clinical characteristics
- Patient and family knowledge regarding physical activity (PA)
- Availability of social support systems
In-Hospital ProgramBehavioural
Based on assessment findings, two structured educational sessions (20-30 minutes each) will be delivered, covering:
- Disease-specific knowledge and PA guidelines
- Practical strategies for safe exercise (e.g., intensity adjustment, injury prevention)
- Interactive demonstrations of age-appropriate movement techniques
In-Hospital ProgramBehavioural
Patients will co-develop personalized PA plans using the six-step self-regulation framework from the ITHBC (Integrative Theory of Health Behavior Change), including:
- Short/long-term goal formulation
- Progress monitoring tools
- Barrier problem-solving protocols
Post-Discharge ProgramBehavioural
Patients will perform PA 3-5 times weekly (20-30 minutes/session) aligned with individualized goals, adhering to oncology-specific safety guidelines
Post-Discharge ProgramBehavioural
Mondays: Curated PA educational content (e.g., home-based exercise videos, fatigue management tips) will be disseminated via the WeChat platform.
Sundays: Scheduled telehealth check-ins with patients and caregivers to:
- Review PA adherence and experiential feedback
- Address knowledge gaps through tailored coaching
- Reinforce behavior change techniques (e.g., self-monitoring logs)
Post-Discharge ProgramBehavioural
Regular monitoring and evaluation will be conducted to assess PA outcomes: comprehensive evaluations will identify barriers (e.g., treatment-related fatigue) and guide real-time adjustments to the exercise plan based on the patient's physical condition and performance. To enhance adherence, families will collaboratively set alarm reminders for PA sessions, and caregivers will be invited to supervise daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Smart wristband to track daily steps, followed a personalized exercise plan, and received weekly guidance Receives: Behavioral: In-Hospital Program; Behavioral: Post-Discharge Program |
| Control group | Placebo comparator | Routine health education Receives: Behavioral: Control group (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
This study assessed physical activity (PA) patterns in children with cancer using the Children's Leisure Time Activities Study Survey-Chinese version (CLASS-C), a culturally adapted instrument developed by thVigorous PA (e.g., running, basketballe Chinese University of Hong Kong through rigorous forward-backward translation and validation. The CLASS-C captures time spent in specific activities over the past 7 days through 21 items, recording frequency (e.g., days/week) and duration (minutes/session) across three intensity categories：Light PA (e.g., walking, stretching); Moderate PA (e.g., cycling, dancing).
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (2)
physical activity self-efficacy
Physical activity (PA) self-efficacy in children with cancer was evaluated using the Chinese Short Version of the Physical Activity Self-Efficacy Scale (SPASES-C), a culturally adapted instrument derived from the original 8-item SPASES through rigorous forward-backward translation and psychometric validation. The SPASES-C assesses confidence in overcoming barriers to PA via 7 Likert-type items scored from 1 ("not confident at all") to 4 ("very confident"), yielding a total range of 7-28 points. Higher total scores reflect stronger self-efficacy beliefs (e.g., 7 = minimal confidence, 28 = maximal confidence). Internal consistency (Cronbach's α = 0.87) and construct validity (CFI = 0.93) were established in pediatric populations through prior studies.
Measured: From enrollment to the end of treatment at 12 weeks
quality of life of children with cancer
This study utilized the Pediatric Quality of Life Inventory™ Generic Core Scales Version 4.0 (PedsQL™ 4.0 Generic Core Scales) to assess the quality of life (QoL) in children diagnosed with cancer. The PedsQL™ 4.0 is a widely validated instrument designed to measure core dimensions of health-related quality of life in pediatric populations aged 2 to 18 years, including physical, emotional, social, and school functioning. Each item is scored on a 5-point Likert scale (0 = never a problem; 4 = almost always a problem), which is then reverse-scored and linearly transformed to a 0-100 scale, where higher scores indicate better quality of life. Thus, the total score as well as subscale scores range from 0 (worst QoL) to 100 (best QoL), with higher values reflecting fewer problems and greater perceived well-being.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start10 Jul 2023
- Primary completion30 Jul 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ke Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor-investigator, Ke Liu, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07003607
- Sponsor's protocol ID
- L2023SYSU-HL-025
- Other IDs
- 2024-FXY-299-Peds Onc
- Status last verified
- May 2025
- First submitted
- 17 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data cannot be shared due to ethical restrictions protecting participant privacy, institutional data governance policies, and the absence of explicit consent for public data sharing in the original study protocol
Publications
Atun R, Bhakta N, Denburg A, Frazier AL, Friedrich P, Gupta S, Lam CG, Ward ZJ, Yeh JM, Allemani C, Coleman MP, Di Carlo V, Loucaides E, Fitchett E, Girardi F, Horton SE, Bray F, Steliarova-Foucher E, Sullivan R, Aitken JF, Banavali S, Binagwaho A, Alcasabas P, Antillon F, Arora RS, Barr RD, Bouffet E, Challinor J, Fuentes-Alabi S, Gross T, Hagander L, Hoffman RI, Herrera C, Kutluk T, Marcus KJ, Moreira C, Pritchard-Jones K, Ramirez O, Renner L, Robison LL, Shalkow J, Sung L, Yeoh A, Rodriguez-Galindo C. Sustainable care for children with cancer: a Lancet Oncology Commission. Lancet Oncol. 2020 Apr;21(4):e185-e224. doi: 10.1016/S1470-2045(20)30022-X.
PubMed 32240612Hudson MM, Ness KK, Gurney JG, Mulrooney DA, Chemaitilly W, Krull KR, Green DM, Armstrong GT, Nottage KA, Jones KE, Sklar CA, Srivastava DK, Robison LL. Clinical ascertainment of health outcomes among adults treated for childhood cancer. JAMA. 2013 Jun 12;309(22):2371-2381. doi: 10.1001/jama.2013.6296.
PubMed 23757085
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Device and Self-Regulation Strategies to Promote Physical Activity Among Children With Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT07003607
- Acronym / sponsor ID
- L2023SYSU-HL-025
- Conditions
- Cancer
- Keywords
- physical activity, childhood cancer, quality of life, physical activity self-efficacy, Integrated theory of health behavior change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Ke LiuUniversity, hospital or other
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 10 Jul 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 4 Jun 2025 (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.
This is a clinical trial that tested whether a 12-week exercise program using smart wristbands and personalized goal-setting could help children with cancer become more active, feel more confident about exercising, and improve their quality of life.
The study included 72 children and teenagers (ages 6-18) receiving cancer treatment at two hospitals in China. They were divided into two groups:
Intervention group (33 children): Used a smart wristband to track daily steps, followed a personalized exercise plan, and received weekly guidance.
Control group (39 children): Continued with usual care (no special exercise program).
The main questions it aims to answer are:
- Does the exercise program help children with cancer move more and sit less;
- Can it boost their confidence to stay active and improve their physical and emotional well-being?
Detailed description
What did the study find?
- Children in the exercise group:
- Increased active time: They did more moderate-to-vigorous exercise (like brisk walking or playing) by the end of the program.
- Walked more steps daily: From about 2,200 steps/day at the start to over 6,300 steps/day after 12 weeks.
- Felt more confident: They believed they could keep exercising even during treatment.
- Improved well-being: Parents and children reported better physical energy, mood, and social interactions.
- Comparison with the control group:
- The exercise group showed much greater improvements than the group without the program.
What does this mean for families? This study suggests that combining wearable devices (like step trackers) with simple goal-setting and family support may help children with cancer stay active during treatment. Staying active could reduce fatigue, improve mood, and support recovery.
What's next? While these results are promising, larger studies are needed to confirm the long-term benefits and safety of such programs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: In-Hospital Program, Behavioral: Post-Discharge ProgramSmart wristband to track daily steps, followed a personalized exercise plan, and received weekly guidance |
| Control group | Placebo comparator | Behavioral: Control group (placebo)Routine health education |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 6 and 18 years old;
- Children diagnosed with leukemia, lymphoma, or solid tumor confirmed by pathology or bone marrow examination;
- Obtaining informed consent from the child and their guardian;
- Approval from the attending physician for participation in physical activity interventions.
Key exclusion criteria (3 listed)
- Children diagnosed with mental health disorders;
- Individuals with severe physical disabilities incompatible with physical activity participation;
- Cases involving metastasis to bone tissue that would restrict movement.
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 |
|---|---|---|
| Control group (placebo)Children in the control group received routine health education, which included cancer-related treatment, care, and general health education (e.g., treatment-related, diet, and exercise) without systematic PA health education. Every four weeks, knowledge related to sports activities, the harms of insufficient physical activity, and the benefits of increasing physical activity were pushed through the WeChat platform. During the hospitalization of the child patient, they can voluntarily participate in the activities organized by social workers. | Behavioural | Control group |
| In-Hospital ProgramResearchers will conduct a comprehensive evaluation for each pediatric patient, including: * Disease status and clinical characteristics * Patient and family knowledge regarding physical activity (PA) * Availability of social support systems | Behavioural | Experimental group |
| In-Hospital ProgramBased on assessment findings, two structured educational sessions (20-30 minutes each) will be delivered, covering: * Disease-specific knowledge and PA guidelines * Practical strategies for safe exercise (e.g., intensity adjustment, injury prevention) * Interactive demonstrations of age-appropriate movement techniques | Behavioural | Experimental group |
| In-Hospital ProgramPatients will co-develop personalized PA plans using the six-step self-regulation framework from the ITHBC (Integrative Theory of Health Behavior Change), including: * Short/long-term goal formulation * Progress monitoring tools * Barrier problem-solving protocols | Behavioural | Experimental group |
| Post-Discharge ProgramPatients will perform PA 3-5 times weekly (20-30 minutes/session) aligned with individualized goals, adhering to oncology-specific safety guidelines | Behavioural | Experimental group |
| Post-Discharge ProgramMondays: Curated PA educational content (e.g., home-based exercise videos, fatigue management tips) will be disseminated via the WeChat platform. Sundays: Scheduled telehealth check-ins with patients and caregivers to: * Review PA adherence and experiential feedback * Address knowledge gaps through tailored coaching * Reinforce behavior change techniques (e.g., self-monitoring logs) | Behavioural | Experimental group |
| Post-Discharge ProgramRegular monitoring and evaluation will be conducted to assess PA outcomes: comprehensive evaluations will identify barriers (e.g., treatment-related fatigue) and guide real-time adjustments to the exercise plan based on the patient's physical condition and performance. To enhance adherence, families will collaboratively set alarm reminders for PA sessions, and caregivers will be invited to supervise daily activities. | Behavioural | Experimental group |
Primary outcome
physical activity
Time frame: From enrollment to the end of treatment at 12 weeks
This study assessed physical activity (PA) patterns in children with cancer using the Children's Leisure Time Activities Study Survey-Chinese version (CLASS-C), a culturally adapted instrument developed by thVigorous PA (e.g., running, basketballe Chinese University of Hong Kong through rigorous forward-backward translation and validation. The CLASS-C captures time spent in specific activities over the past 7 days through 21 items, recording frequency (e.g., days/week) and duration (minutes/session) across three intensity categories：Light PA (e.g., walking, stretching); Moderate PA (e.g., cycling, dancing).
2 secondary outcomes
physical activity self-efficacy
Time frame: From enrollment to the end of treatment at 12 weeks
quality of life of children with cancer
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Background: PubMed 32240612Atun R, Bhakta N, Denburg A, Frazier AL, Friedrich P, Gupta S, Lam CG, Ward ZJ, Yeh JM, Allemani C, Coleman MP, Di Carlo V, Loucaides E, Fitchett E, Girardi F, Horton SE, Bray F, Steliarova-Foucher E, Sullivan R, Aitken JF, Banavali S, Binagwaho A, Alcasabas P, Antillon F, Arora RS, Barr RD, Bouffet E, Challinor J, Fuentes-Alabi S, Gross T, Hagander L, Hoffman RI, Herrera C, Kutluk T, Marcus KJ, Moreira C, Pritchard-Jones K, Ramirez O, Renner L, Robison LL, Shalkow J, Sung L, Yeoh A, Rodriguez-Galindo C. Sustainable care for children with cancer: a Lancet Oncology Commission. Lancet Oncol. 2020 Apr;21(4):e185-e224. doi: 10.1016/S1470-2045(20)30022-X.
- Results publication: PubMed 23757085Hudson MM, Ness KK, Gurney JG, Mulrooney DA, Chemaitilly W, Krull KR, Green DM, Armstrong GT, Nottage KA, Jones KE, Sklar CA, Srivastava DK, Robison LL. Clinical ascertainment of health outcomes among adults treated for childhood cancer. JAMA. 2013 Jun 12;309(22):2371-2381. doi: 10.1001/jama.2013.6296.
- Individual participant dataSharing planned: No. Individual participant data cannot be shared due to ethical restrictions protecting participant privacy, institutional data governance policies, and the absence of explicit consent for public data sharing in the original study protocol
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-Hospital Program and Post-Discharge Program in people with Cancer, run by Ke Liu at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
physical activity (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07003607, which also lists 2 linked publications.
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 4 Jun 2025.