What side effects are associated with this type of intervention?

Common treatments for cancer, such as chemotherapy and blood stem cell transplants, often come with a range of side effects. Chemotherapy can cause nausea, vomiting, fatigue, hair loss, and increased susceptibility to infections due to lowered white blood cell counts. Blood stem cell transplants may lead to complications like graft-versus-host disease, infections, and organ damage. Supportive interventions like the TEAM Me exercise program aim to improve physical fitness, quality of life, and function, potentially mitigating some of these side effects.

What prior FDA approvals exist?

The TEAM Me trial is unique in its focus on behavioral reinforcement through a token system to improve exercise and dietary habits in pediatric and young adult cancer patients undergoing blood stem cell transplants. While there are no specific FDA-approved cancer treatments that use a similar token-based behavioral reinforcement system, the FDA has approved various pharmacological treatments for cancer, including targeted therapies like dabrafenib and trametinib for BRAF V600-mutant melanoma, and immunotherapies such as pembrolizumab for various types of cancer. These treatments focus on directly targeting cancer cells or enhancing the immune system's ability to fight cancer.

What other types of research exist?

Promising, novel alternatives to the TEAM Me program for cancer patients include: 1) Technology-enhanced outpatient symptom management systems using electronic patient-reported outcomes and sensor-enabled vital signs capture, 2) Automated health chats for symptom management and patient-reported outcomes, and 3) Virtual reality interventions for symptom management in solid-tumor patients.

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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 below

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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

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

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 more

Awards & 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

0 / 3Eligibility criteria met

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.