Web-Based Physical Activity for Childhood Cancer Survivor Health

Recruiting at 124 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Children's Oncology Group

Disqualifiers: Hematopoietic stem cell transplant, Pregnancy, Cognitive impairment, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 24

300 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized clinical phase III trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with cancer. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.

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 data supports the effectiveness of the treatment Web-Based Physical Activity Intervention for childhood cancer survivors?

Research shows that web-based physical activity programs can help childhood cancer survivors increase their exercise levels, which may improve their overall health and quality of life. A study found that such interventions can boost moderate to vigorous physical activity and enhance fitness and well-being over 24 weeks. ^{1 2 3 4 5}

Is web-based physical activity intervention safe for childhood cancer survivors?

The research on web-based physical activity interventions for cancer survivors, including young adults and adolescents, suggests that these programs are generally safe and well-received. Participants found the interventions easy to use and were satisfied with the experience, indicating no significant safety concerns. ^{1 2 3 4 6}

How is the Web-Based Physical Activity Intervention treatment different from other treatments for childhood cancer survivors?

The Web-Based Physical Activity Intervention is unique because it uses the internet to encourage physical activity among childhood cancer survivors, making it accessible and engaging for children who are already familiar with online platforms. Unlike traditional treatments, this approach leverages technology to provide personalized support and motivation, which can be more appealing and convenient for young users. ^{7 8 9 10 11}

Research Team

Kirsten K Ness

Principal Investigator

Children's Oncology Group

Eligibility Criteria

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

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

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Arm II (tracking device, interactive-reward based device) Experimental Treatment 6 Interventions

Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients for 6 months.

Group II: Arm I (tracking device, limited version of device) Active Control 6 Interventions

Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of device app/website to get basic information related to their physical activity for 6 months.

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Fitbit and Facebook mHealth intervention for promoting physical activity among adolescent and young adult childhood cancer survivors: A pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Group Physical Activity Intervention for Childhood Cancer Survivors: A Pilot Study. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Using qualitative and co-design methods to inform the development of an intervention to support and improve physical activity in childhood cancer survivors: a study protocol for BEing Active after ChildhOod caNcer (BEACON). [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized web-based physical activity intervention in adolescent survivors of childhood cancer. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A home-based physical activity intervention using activity trackers in survivors of childhood cancer: A pilot study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Internet-Based Physical Activity Intervention Targeting Young Adult Cancer Survivors. [2022]

7. Norway pubmed.ncbi.nlm.nih.gov

Interdisciplinary, child-centred collaboration could increase the success of potentially successful Internet-based physical activity interventions. [2016]

8. Canada pubmed.ncbi.nlm.nih.gov

Development and usability testing of an internet intervention to increase physical activity in overweight adolescents. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Computer- and web-based interventions to increase preadolescent and adolescent physical activity: a systematic review. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

A Diabetic Adolescent Case Study: Use of a Website in Combination with an Exercise Program to Increase Physical Activity. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Effect of a Web-based intervention to promote physical activity and improve health among physically inactive adults: a population-based randomized controlled trial. [2022]