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Exercise Program for Pediatric Cancer Mobility

N/A
Recruiting
Led By Priti Tewari
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be admitted to an inpatient pediatric ward for the purpose of HSCT for the treatment of malignancy
Be greater than or equal to 6 years of age and less than 30 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days post-hsct
Awards & highlights

Study Summary

This trial is testing an exercise program to see if it can help kids with cancer who are undergoing blood stem cell transplants. The program uses stickers as rewards to help kids stay active.

Who is the study for?
This trial is for pediatric and young adult cancer patients aged 6 to less than 30 years, undergoing blood stem cell transplant. They must be able to consent and follow study procedures. It's not for those with conditions that limit physical activity or those admitted to adult units at MD Anderson.Check my eligibility
What is being tested?
The TEAM Me exercise program is being tested, which uses rewards like stickers to encourage walking and other activities in young cancer patients during a stem cell transplant. The impact on fitness, activity levels, quality of life, and function will be measured.See study design
What are the potential side effects?
Since this intervention involves an exercise program rather than medication, side effects may include typical exercise-related issues such as muscle soreness or fatigue but should generally be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am admitted to a hospital for a stem cell transplant to treat cancer.
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I am between 6 and 30 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days post-hsct
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days post-hsct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events.
Proportion of patients who enroll and complete the serial measures
Secondary outcome measures
Change in 30 second sit-to-stand test
Walk Test
Change in Borg Rating of Perceived Exertion
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (TEAM Me)Experimental Treatment4 Interventions
Patients complete a 6-minute walk test and a timed get up and go test on the day of hospital admission, on days 0 (day of stem cell transplant) and 21, the day of discharge, and day 100. Patients also complete surveys over 10 minutes about quality of life and fatigue levels on the day of hospital admission, on days 0 (day of stem cell transplant) and 21, the day of discharge, and day 100. Patients who are able and allowed to, may also walk and participate in other intense physical activities to earn stickers. Patients who are unable to walk have tailored goals created by a physical/occupational therapist to earn stickers and participate in physical activity as prescribed by their therapist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Intervention
2021
Completed Phase 4
~3740

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,977 Previous Clinical Trials
1,789,429 Total Patients Enrolled
Priti TewariPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

TEAM Me Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT04678427 — N/A
Cancer Research Study Groups: Supportive Care (TEAM Me)
Cancer Clinical Trial 2023: TEAM Me Exercise Program Highlights & Side Effects. Trial Name: NCT04678427 — N/A
TEAM Me Exercise Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04678427 — N/A

Frequently Asked Questions

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

Are there any vacancies available in this trial for participants?

"Affirmative. The information from clinicaltrials.gov demonstrates that this trial is actively looking for participants, with the initial posting on November 13th 2020 and most recent update on April 21st 2022. This research project requires enrollment of 60 individuals across two separate sites."

Answered by AI

For what types of individuals is this research initiative most suitable?

"To qualify for this clinical research, applicants must be aged between 6 and 29 with evidence of lymphoid cells. Currently, a total of 60 individuals are being admitted to the trial."

Answered by AI

Does this experiment have an age restriction, and if so, what is it?

"Eligibility for enrolment in this clinical trial requires a person to be between 6 and 29 years of age."

Answered by AI

How many participants are involved in this experimental protocol?

"Affirmative. According to clinicaltrials.gov, the trial is currently recruiting participants; it was first posted on November 13th 2020 and recently updated on April 21st 2022. There are 60 spots available between two sites."

Answered by AI

What goals has this clinical trial set forth?

"The primary purpose of this research is to monitor the prevalence of adverse events in patients up to 21 days after a hematopoietic stem cell transplant (HSCT). Secondary objectives include assessing changes in Wee Functional Independence Measure (FIM)/FIM, gross grip hand strength, and timed up and go tests. Statistical analysis such as descriptive statistics, Wilcoxon rank sum test, Wilcoxon signed-rank test, repeated measures analysis will be performed with controlling for potential confounding factors like age, gender etc., all 2-sided testing at 0.05 significance level."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Exercise Program (TEAM Me) for the Improvement of Movement and Mobility in Pediatric and Adolescent and Young Adult Patients With Cancer Undergoing a Blood Stem Cell Transplant
2020. "Exercise Program (TEAM Me) for the Improvement of Movement and Mobility in Pediatric and Adolescent and Young Adult Patients With Cancer Undergoing a Blood Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678427.
~19 spots leftby Dec 2025
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