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Web-Based Physical Activity for Childhood Cancer Survivor Health

Phase 3

Waitlist Available

Led By Kirsten K Ness

Research Sponsored by Children's Oncology Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the past 12 months at a Childrens Oncology Group (COG) institution

Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years of age

Must not have

Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test

Female patient who is postmenarcheal and has not agreed to use an effective contraceptive method (including abstinence) for the duration of study participation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 weeks post intervention

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a web-based physical activity intervention to see if it can help improve the long term health of children and adolescents who have had cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this isn't a drug trial but an exercise intervention study via online platforms and physical activity trackers there are no direct side effects like those associated with medication. However general risks of increasing physical activity may include muscle soreness or injury.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I finished my cancer treatment at a COG institution within the last year.

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I can take care of myself but may not be able to do heavy physical work.

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My cancer is either in situ or malignant and currently in remission.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant and have a negative pregnancy test.

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I am a woman who can have children and agree to use birth control during the study.

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I have had a bone marrow transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 weeks post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 weeks post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 weeks post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Physiologic cost index (PCI)

Secondary study objectives

Change in fatigue

Change in inflammation

Change in markers of cardiometabolic health

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (tracking device, interactive-reward based device)Experimental Treatment6 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 Control6 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Medical Device Usage and Evaluation

2021

N/A

~160

0 / 6Eligibility criteria met