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

NCT07003607 | Completed

• 2 other identifiers: L2023SYSU-HL-0252024-FXY-299-Peds Onc
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Keywords

physical activity; childhood cancer; quality of life; physical activity self-efficacy; Integrated theory of health behavior change

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• physical activity self-efficacy

  From enrollment to the end of treatment at 12 weeks

• quality of life of children with cancer

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Smart wristband to track daily steps, followed a personalized exercise plan, and received weekly guidance

Behavioral: In-Hospital Program; Behavioral: Post-Discharge Program

Control group

PLACEBO COMPARATOR

Routine health education

Behavioral: Control group (placebo)

Interventions

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.

Control group

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

Experimental group

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

Experimental group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ke Liu: lead
• Sun Yat-sen University Cancer Centre: collaborator

Study Sites (1)

Sun Yat-sen University Cancer Prevention Center

Guangzhou, Guangdong, 510080, China

Location

Related Publications (2)

• 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.

  PMID: 32240612 BACKGROUND

• 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.

  PMID: 23757085 RESULT

MeSH Terms

Conditions

Neoplasms; Motor Activity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2025
• First Posted: June 4, 2025
• Study Start: July 10, 2023
• Primary Completion: July 30, 2024
• Study Completion: December 25, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)