Wearable Device and Self-Regulation Strategies to Promote Physical Activity Among Children With Cancer: A Pilot Study
- Conditions
- Cancer
- Registration Number
- NCT07003607
- Lead Sponsor
- Ke Liu
- Brief 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.
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?
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Primary Outcome Measures
Name Time Method physical activity 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 Outcome Measures
Name Time Method physical activity self-efficacy 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.
quality of life of children with cancer 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.
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Prevention Center
🇨🇳GuangZhou, Guangdong, China