Wearable Device and Self-Regulation Strategies to Promote Physical Activity Among Children With Cancer: A Pilot 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:

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:

1. Does the exercise program help children with cancer move more and sit less;
2. Can it boost their confidence to stay active and improve their physical and emotional well-being?

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: In-Hospital Program; Behavioral: In-Hospital Program; Behavioral: In-Hospital Program; Behavioral: Post-Discharge Program; Behavioral: Post-Discharge Program; Behavioral: Post-Discharge Program; Behavioral: Control group (placebo)

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 Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • GuangZhou, Guangdong, China, 510080
      • Sun Yat-sen University Cancer prevention Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Smart wristband to track daily steps, followed a personalized exercise plan, and received weekly guidance	Behavioral: In-Hospital Program; 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; Behavioral: In-Hospital Program; 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; Behavioral: In-Hospital Program; 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; Behavioral: Post-Discharge Program; Patients will perform PA 3-5 times weekly (20-30 minutes/session) aligned with individualized goals, adhering to oncology-specific safety guidelines; Behavioral: Post-Discharge Program; 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); Behavioral: Post-Discharge Program; 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.
Placebo Comparator: Control group; Routine health education	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of treatment at 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

• Sponsor: Ke Liu
• Collaborators: Sun Yat-sen University Cancer Centre

Publications and helpful links

General 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.
• Hudson 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): December 25, 2024

Study Registration Dates

• First Submitted: May 17, 2025
• First Submitted That Met QC Criteria: May 26, 2025
• First Posted (Actual): June 4, 2025

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; quality of life; childhood cancer; physical activity self-efficacy; Integrated theory of health behavior change
• Other Study ID Numbers: L2023SYSU-HL-025; 2024-FXY-299-Peds Onc (Other Identifier: Sun Yat-Sen University Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No