Web-Based Physical Activity for Childhood Cancer Survivor Health

Not currently recruiting at 129 trial locations
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Children's Oncology Group
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a web-based physical activity program can improve the long-term health of children and teens who have survived cancer. It encourages regular exercise, which may help maintain a healthy weight and boost energy. Participants will use a tracking device and an app to monitor their activity levels. Children or teens who completed cancer treatment within the last year and are not very active might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking health program.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this web-based physical activity intervention is safe for childhood cancer survivors?

Research shows that online exercise programs for children who have survived cancer are generally safe. Studies have found that participants handle these programs well. For instance, a fun, reward-based program designed to increase physical activity succeeded with teenage cancer survivors. Participants used the program and gained benefits without major problems.

Although specific side effects are not mentioned, the study's Phase 3 status indicates earlier stages have already demonstrated safety. In clinical trials, reaching Phase 3 means the treatment has been tested on smaller groups and deemed safe for further testing. This should reassure participants that the online exercise program is considered safe.12345

Why are researchers excited about this trial?

Researchers are excited about this web-based physical activity intervention for childhood cancer survivors because it leverages technology to encourage healthier lifestyles in a unique way. Unlike traditional treatments that might focus solely on medical or nutritional interventions, this approach uses engaging, interactive digital tools to motivate kids to be active. It combines educational resources with a tracking device and an interactive app that rewards users for meeting activity goals, fostering a sense of community and support among participants. This method not only promotes physical wellness but also encourages social interaction, which can be crucial for long-term health and recovery.

What evidence suggests that this web-based physical activity intervention is effective for improving long-term health in childhood cancer survivors?

Research has shown that online exercise programs can improve the health of children who have survived cancer. These programs often include fun activities and rewards to encourage participation. In this trial, participants in Arm I will use a tracking device and access a limited version of the device app/website, while those in Arm II will use a tracking device and access the full version of an interactive, reward-based device app/website. One study found that such programs increase moderate to vigorous exercise, which links to better overall health. Another study suggested that regular exercise helps maintain a healthy weight and boosts energy levels. Therefore, these programs could be a promising way to support long-term health in children who have beaten cancer.12678

Who Is on the Research Team?

KK

Kirsten K Ness

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for children and adolescents in remission from various cancers, who've completed treatment within the last year at a COG institution. They should be moderately inactive, able to perform daily activities (with some limitations), and along with a parent or guardian, read and write English, Spanish, or French. Those with stem cell transplants, significant health issues that affect study participation or pregnant females can't join.

Inclusion Criteria

All patients and/or their parents or legal guardians must sign a written informed consent
I finished my cancer treatment at a COG institution within the last year.
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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Exclusion Criteria

I am not pregnant and have a negative pregnancy test.
I am a woman who can have children and agree to use birth control during the study.
Patients with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in a web-based physical activity intervention with or without structured social interaction, wearing a tracking device and uploading data weekly.

24 weeks
Weekly data uploads

Follow-up

Participants are monitored for changes in cardiometabolic health, quality of life, fatigue, and school attendance.

24 weeks
Follow-up assessments at 24 and 48 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Web-Based Physical Activity Intervention
Trial Overview The trial tests if a web-based physical activity program improves long-term health in young cancer survivors. It includes educational content, internet tools for tracking activity levels using medical devices, lab marker analysis to monitor changes in health status due to exercise, quality-of-life assessments through surveys.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (tracking device, interactive-reward based device)Experimental Treatment6 Interventions
Group II: Arm I (tracking device, limited version of device)Active Control6 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials
467
Recruited
241,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

A web-based program called Young & Active was developed to increase physical activity among overweight adolescents, incorporating features like self-monitoring, autonomy-supportive counseling, and social support forums, based on theories of self-determination and motivational interviewing.
Usability testing with adolescents aged 12-16 showed that the program was well accepted after iterative adjustments, indicating a strong foundation for further evaluation of its efficacy in a controlled trial.
Development and usability testing of an internet intervention to increase physical activity in overweight adolescents.Riiser, K., Løndal, K., Ommundsen, Y., et al.[2021]
A web-based technology support program combined with weekly exercise sessions significantly increased physical activity levels in diabetic adolescents, as evidenced by improvements in daily steps and exercise self-efficacy.
The program included a 30-minute educational session followed by 60 minutes of exercise, demonstrating that structured support can effectively promote physical activity and proper nutrition in children.
A Diabetic Adolescent Case Study: Use of a Website in Combination with an Exercise Program to Increase Physical Activity.Buckley, DH., Ainsworth, MM., Demilia, N., et al.[2019]
A study involving 12,287 physically inactive adults found that access to a website providing tailored feedback on increasing physical activity did not lead to significant improvements in overall physical activity levels compared to a control group.
While only a small percentage of participants actively used the website, those who did showed improvements in their physical activity levels, suggesting that more engaging and sophisticated interventions are needed to motivate unmotivated users.
Effect of a Web-based intervention to promote physical activity and improve health among physically inactive adults: a population-based randomized controlled trial.Hansen, AW., Grønbæk, M., Helge, JW., et al.[2022]

Citations

Randomized web-based physical activity intervention in ...Healthy lifestyle choices including participation in regular physical activity may improve health outcomes in survivors of childhood cancer.
Randomized web-based physical activity intervention in ...Background: This study of adolescent survivors of childhood cancer evaluated the initial efficacy of a web-delivered, interactive, rewards-based physical ...
A Web-Based Physical Activity Intervention in Adolescent ...Five year survival following a diagnosis of childhood cancer has reached 83%, making long term health outcomes among survivors an important ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/29722481/
Randomized web-based physical activity intervention in ...Conclusions: An interactive, rewards-based intervention designed to increase MVPA is feasible in adolescent survivors of childhood cancer.
Design and methods of a randomized web-based physical ...In-person exercise interventions demonstrate that children with cancer and young survivors have improved function and fitness in response to exercise [16].
Implementing an online-delivered exercise program for ...This is the first study to investigate the implementation and delivery of an online exercise program to childhood cancer survivors in conjunction with a ...
Pilot Feasibility and Acceptability Study - JMIR CancerA home-based physical activity intervention using activity trackers in survivors of childhood cancer: a pilot study.
Web-Based Physical Activity Intervention in Improving ...This randomized clinical phase III trial studies how well web-based physical activity intervention works in improving long term health in children and ...
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