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

NCT ID: NCT07003607

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-12-25

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental group

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

Group Type EXPERIMENTAL

In-Hospital Program

Intervention Type 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

In-Hospital Program

Intervention Type BEHAVIORAL

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

In-Hospital Program

Intervention Type BEHAVIORAL

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

Post-Discharge Program

Intervention Type BEHAVIORAL

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

Post-Discharge Program

Intervention Type BEHAVIORAL

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)

Post-Discharge Program

Intervention Type BEHAVIORAL

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.

Control group

Routine health education

Group Type PLACEBO_COMPARATOR

Control group (placebo)

Intervention Type 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.

Interventions

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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.

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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)

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University Cancer Centre

UNKNOWN

Sponsor Role collaborator

Ke Liu

OTHER

Sponsor Role lead

Responsible Party

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Ke Liu

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sun Yat-sen University Cancer Prevention Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 32240612 (View on PubMed)

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.

Reference Type RESULT
PMID: 23757085 (View on PubMed)

Other Identifiers

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2024-FXY-299-Peds Onc

Identifier Type: OTHER

Identifier Source: secondary_id

L2023SYSU-HL-025

Identifier Type: -

Identifier Source: org_study_id

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