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Web-Based Physical Activity for Childhood Cancer Survivor Health

Q: What are the risks associated with using an online service for health care?

There is some data supporting the efficacy of this intervention, and multiple rounds of data have been collected to support its safety. Therefore, it received a score of 3.

Q: Will this clinical trial be accommodating to patients that are elderly?

This clinical trial is enrolling candidates who are between 8-16 years old.

Q: Are we still enrolling individuals in this experiment?

That is correct, the trial detailed on clinicaltrials.gov is currently recruiting patients. The study was first made public on 8/14/2017 and has since been updated on 10/19/2022. In total, 384 patients are needed for this trial which will be conducted at 100 sites.

Q: In how many different hospitals is this trial taking place?

One hundred different clinical trial sites are currently recruiting patients for this study. The locations of the centres are in cities such as Tacoma, <a href="https://www.withpower.com/clinical-trials/oklahoma">Oklahoma</a> City, Detroit and many others. If you choose to participate in this trial, it would be advantageous to select a clinic that is close to your location to limit travel.

Q: What is the total number of people taking part in this clinical trial?

In order to move forward with this clinical trial, we need to enroll 384 patients that fit the pre-determined inclusion criteria. Fortunately, there are multiple locations across the country where patients can participate, such as Mary Bridge Children's Hospital and Health Center in Tacoma, <a href="https://www.withpower.com/clinical-trials/washington">Washington</a> and University of <a href="https://www.withpower.com/clinical-trials/oklahoma">Oklahoma</a> Health Sciences Center in Oklahoma City, Oklahoma.

Q: How can I enroll myself in this clinical trial?

This trial is looking for 384 participants with neoplasms aged 8 and 16. Most notable, applicants must meet the following criteria: Patients must have a performance status corresponding to Eastern Cooperative <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a> Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =&#x3C; 16 years of age, At the time of consent, patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week, <a href="https://www.withpower.com/clinical-trials/all">All</a> <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> cases with an International Classification of Diseases for Oncology (ICD)-O histologic behavior code of two "2" (carcinoma in situ)

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 weeks post intervention

Awards & highlights

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.

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.Check my eligibility

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.See study design

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

Select...

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

Select...

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Physiologic cost index (PCI)

Secondary outcome measures

Change in fatigue

Change in inflammation

Change in markers of cardiometabolic health

+3 more

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

~150

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,694 Previous Clinical Trials

40,929,372 Total Patients Enrolled

1,397 Trials studying Carcinoma

387,413 Patients Enrolled for Carcinoma

Children's Oncology GroupLead Sponsor

455 Previous Clinical Trials

239,212 Total Patients Enrolled

10 Trials studying Carcinoma

12,515 Patients Enrolled for Carcinoma

Kirsten K NessPrincipal InvestigatorChildren's Oncology Group

Media Library

Web-Based Physical Activity Intervention Clinical Trial Eligibility Overview. Trial Name: NCT03223753 — Phase 3

Carcinoma Research Study Groups: Arm II (tracking device, interactive-reward based device), Arm I (tracking device, limited version of device)

Carcinoma Clinical Trial 2023: Web-Based Physical Activity Intervention Highlights & Side Effects. Trial Name: NCT03223753 — Phase 3

Web-Based Physical Activity Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT03223753 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with using an online service for health care?

"There is some data supporting the efficacy of this intervention, and multiple rounds of data have been collected to support its safety. Therefore, it received a score of 3."

Answered by AI

Will this clinical trial be accommodating to patients that are elderly?

"This clinical trial is enrolling candidates who are between 8-16 years old."

Answered by AI

Are we still enrolling individuals in this experiment?

"That is correct, the trial detailed on clinicaltrials.gov is currently recruiting patients. The study was first made public on 8/14/2017 and has since been updated on 10/19/2022. In total, 384 patients are needed for this trial which will be conducted at 100 sites."

Answered by AI

In how many different hospitals is this trial taking place?

"One hundred different clinical trial sites are currently recruiting patients for this study. The locations of the centres are in cities such as Tacoma, Oklahoma City, Detroit and many others. If you choose to participate in this trial, it would be advantageous to select a clinic that is close to your location to limit travel."

Answered by AI

What is the total number of people taking part in this clinical trial?

"In order to move forward with this clinical trial, we need to enroll 384 patients that fit the pre-determined inclusion criteria. Fortunately, there are multiple locations across the country where patients can participate, such as Mary Bridge Children's Hospital and Health Center in Tacoma, Washington and University of Oklahoma Health Sciences Center in Oklahoma City, Oklahoma."

Answered by AI

How can I enroll myself in this clinical trial?

"This trial is looking for 384 participants with neoplasms aged 8 and 16. Most notable, applicants must meet the following criteria: 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, At the time of consent, patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week, All cancer cases with an International Classification of Diseases for Oncology (ICD)-O histologic behavior code of two "2" (carcinoma in situ)"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

2017. "Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03223753.

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