Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

300

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Nov 2017

Longer than P75 for phase_3

Geographic Reach

2 countries

118 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8.3 years study duration

First Submitted

Initial submission to the registry

July 11, 2017

Completed

10 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed

4 months until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed

7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed

Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

7.3 years

First QC Date

July 11, 2017

Last Update Submit

April 16, 2025

Conditions

Carcinoma In Situ Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (1)

Physiologic cost index (PCI)
Differences in PCI will be compared between groups at the end of the intervention. Intent to treat analysis of variance (either transforming the data or employing a non-parametric equivalent if the data are not normally distributed) controlling for the stratification factors (sex, age, and treatment related risk group) will be used for comparison. General linear mixed models will be utilized to evaluate the effects of group assignment on changes in PCI over time to account for repeated measures on individual children, and for potential random effects such as original treating institution.
Up to 24 weeks (end of intervention)

Secondary Outcomes (6)

Change in markers of cardiometabolic health
Baseline up to 48 weeks post intervention
Change in inflammation
Baseline up to 48 weeks post intervention
Change in quality of life
Baseline up to 48 weeks post intervention
Change in fatigue
Baseline up to 48 weeks post intervention
Change in school attendance
Baseline up to 48 weeks post intervention
+1 more secondary outcomes

Study Arms (2)

Arm I (tracking device, limited version of device)

ACTIVE COMPARATOR

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.

Other: Educational InterventionOther: Internet-Based InterventionOther: Laboratory Biomarker AnalysisDevice: Medical Device Usage and EvaluationOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (tracking device, interactive-reward based device)

EXPERIMENTAL

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.

Interventions

Educational InterventionOTHER

Receive educational handouts about to physical activity

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational