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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
Must not have
Patients whose clinical status precludes them from participating in any physical activity including but not limited to: declining respiratory status, hypoxia requiring high flow nasal cannula (Vapotherm), hypotension, and active bleeding.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days post-hsct
Awards & highlights
No Placebo-Only Group
Summary
This trial studies how the TEAM Me exercise program affects kids and young adults with cancer. The program gives them stickers for exercising, which they can trade for prizes. This helps them stay active and improve their fitness and quality of life.
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.
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.
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 belowSelect...
I am admitted to a hospital for a stem cell transplant to treat cancer.
Select...
I am between 6 and 30 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot do any physical activity due to severe health issues like breathing problems or active bleeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 100 days post-hsct
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days post-hsct
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events.
Proportion of patients who enroll and complete the serial measures
Secondary study objectives
Change in 30 second sit-to-stand test
Walk Test
Change in Borg Rating of Perceived Exertion
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The TEAM Me trial emphasizes behavioral reinforcement to improve exercise and dietary habits, which can significantly enhance the quality of life and physical function in cancer patients. Common cancer treatments include chemotherapy, which targets rapidly dividing cells to kill cancer cells; radiation therapy, which uses high-energy particles to destroy cancer cells; and targeted therapy, which blocks specific molecules involved in cancer growth and progression.
These treatments are crucial as they aim to reduce tumor size, prevent metastasis, and improve survival rates. Integrating behavioral interventions like TEAM Me can complement these treatments by promoting healthier lifestyles, potentially improving treatment outcomes and overall well-being.
[Measuring quality of life as an integral component of quality management in surgical medicine].Promoting Healthy Eating and Physical Activity Behaviors: A Systematic Review of Multiple Health Behavior Change Interventions Among Cancer Survivors.Group-based exercise interventions for increasing physical activity in cancer survivors: a systematic review of face-to-face randomized and non-randomized trials.
[Measuring quality of life as an integral component of quality management in surgical medicine].Promoting Healthy Eating and Physical Activity Behaviors: A Systematic Review of Multiple Health Behavior Change Interventions Among Cancer Survivors.Group-based exercise interventions for increasing physical activity in cancer survivors: a systematic review of face-to-face randomized and non-randomized trials.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,063 Previous Clinical Trials
1,800,721 Total Patients Enrolled
Priti TewariPrincipal InvestigatorM.D. Anderson Cancer Center
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I, or my guardian, agree to sign up for the Fitbit study PA18-0130.I am admitted to a hospital for a stem cell transplant to treat cancer.I cannot do any physical activity due to severe health issues like breathing problems or active bleeding.I am between 6 and 30 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive Care (TEAM Me)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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