Internet-Based Intervention for Neoplasms

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Neoplasms+4 More
Internet-Based Intervention - Other
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Neoplasms
  • Carcinoma
  • Malignant Solid Neoplasms

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 48 weeks post intervention

Week 48
Change in fatigue
Change in inflammation
Change in markers of cardiometabolic health
Change in quality of life
Change in school attendance
Week 24
Physiologic cost index (PCI)
Week 48
Markers of cardiometabolic health

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm I (tracking device, limited version of device)
1 of 2
Arm II (tracking device, interactive-reward based device)
1 of 2
Active Control
Experimental Treatment

384 Total Participants · 2 Treatment Groups

Primary Treatment: Internet-Based Intervention · No Placebo Group · Phase 3

Arm II (tracking device, interactive-reward based device)Experimental Group · 6 Interventions: Questionnaire Administration, Medical Device Usage and Evaluation, Quality-of-Life Assessment, Internet-Based Intervention, Laboratory Biomarker Analysis, Educational Intervention · Intervention Types: Other, Device, Other, Other, Other, Other
Arm I (tracking device, limited version of device)ActiveComparator Group · 6 Interventions: Questionnaire Administration, Medical Device Usage and Evaluation, Quality-of-Life Assessment, Internet-Based Intervention, Laboratory Biomarker Analysis, Educational Intervention · Intervention Types: Other, Device, Other, Other, Other, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Medical Device Usage and Evaluation
2021
N/A
~30

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 48 weeks post intervention

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
446 Previous Clinical Trials
234,706 Total Patients Enrolled
85 Trials studying Neoplasms
65,387 Patients Enrolled for Neoplasms
National Cancer Institute (NCI)NIH
12,991 Previous Clinical Trials
41,298,109 Total Patients Enrolled
1,306 Trials studying Neoplasms
5,160,412 Patients Enrolled for Neoplasms
Kirsten K NessPrincipal InvestigatorChildren's Oncology Group

Eligibility Criteria

Age < 18 · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
At least one parent or guardian can read and write English, Spanish, and/or French; at least one parent or guardian must be able to read and write English, Spanish, and/or French in order to help the patient use their physical activity tracking device account.
Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; Lansky performance status =< 16 years of age.
The patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week.
You have cancer with a specific ICD-O code of two \"2\" or three \"3\" in remission.
The patient must have completed their curative therapy within the past 12 months at a Childrens Oncology Group institution.
, and documented, before initiation of the study
You must sign a written informed consent before you can receive any treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: October 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.