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Completed

NCT Number: NCT07003607

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?

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University Cancer Prevention Center

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control group (placebo)

Behavioral

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 Program

Behavioral

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

Post-Discharge Program

Behavioral

Patients will perform PA 3-5 times weekly (20-30 minutes/session) aligned with individualized goals, adhering to oncology-specific safety guidelines

Primary outcomes

  1. 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).

Secondary outcomes

  1. physical activity self-efficacy

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

  2. quality of life of children with cancer

    Time frame: From enrollment to the end of treatment at 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Ke Liu

Other

Collaborators

  • Sun Yat-Sen University Cancer Center

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 4, 2025
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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