Clinical trial NCT07003607: Wearable Device and Self-Regulation Strategies to Promote Physical Activity Among Children With Cancer: A Pilot Study
Official title: Wearable Device and Self-Regulation Strategies to Promote Physical Activity Among Children With Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: physical activity
childhood cancer
quality of life
physical activity self-efficacy
Integrated theory of health behavior change
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University Cancer Centre
First posted: 2025-06-04
Enrollment: 72
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: physical activity
timeFrame: From enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: physical activity self-efficacy
timeFrame: From enrollment to the end of treatment at 12 weeks
measure: quality of life of children with cancer
timeFrame: From enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Sun Yat-sen University Cancer Prevention Center
state: Guangdong
Study officials:
References:
citation: 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.
citation: 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.