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

TEAM Me (Totally Excited About Moving, Mobility, and Exercise) Clinical Research Protocol

This clinical trial studies how well an exercise program (Totally Excited About Moving, Mobility, and Exercise [TEAM Me]) affects the exercise and dietary habits of pediatric and adolescents and young adults with cancer undergoing a blood stem cell transplant. TEAM Me is an exercise program that reinforces behavior, such as walking and other activities, using "tokens" (i.e. stickers) that can be redeemed for rewards. Participating in the exercise program may result in increased physical fitness, physical activity level, quality of life, and function in pediatric and adolescents and young adult patients with cancer.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Intervention / Treatment: Other: Survey Administration; Other: 6 Minute Walk Functional Test; Behavioral: Behavioral Intervention; Behavioral: Timed Get Up and Go Test

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate the feasibility and tolerability of this exercise program using a token economy system in hospitalized pediatric and adolescent and young adult (AYA) undergoing hematopoietic stem cell transplant (HSCT).

SECONDARY OBJECTIVES:

I. To evaluate the impact of an exercise program using a token economy system in hospitalized pediatric and adolescent and young adult (AYA) cancer patients going through HSCT on measures of physical fitness.

II. To evaluate the impact of an exercise program using a token economy system in hospitalized pediatric and adolescent and young adult (AYA) cancer patients going through HSCT on physical activity.

III. To evaluate the impact of an exercise program using a token economy system in hospitalized pediatric and adolescent and young adult (AYA) cancer patients on quality of life, fatigue, sleep and function.

OUTLINE:

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Priti Tewari; Phone Number: 713-792-6620; Email: ptewari@mdanderson.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • UT Southwestern/Simmons Cancer Center-Dallas
      • Principal Investigator: Victor Aquino, MD
      • Contact: Victor Aquino, MD; Phone Number: 214-730-5437; Email: Victor.Aquino@UTSouthwestern.edu
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Priti Tewari; Phone Number: 713-792-6620
      • Principal Investigator: Priti Tewari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 29 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• Participants or guardians are willing and able to give written informed consent either prior to admission or within 48 hours following admission and to comply with all of the study activities and procedures
• Participants or guardians are willing and able to give written informed consent for protocol PA18-0130 (Pediatric Energy balance data repository protocol), companion protocol for the Fitbit application/assessment

Exclusion Criteria:

• 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.
• At MD Anderson HSCT patients admitted to adult units for their transplant will not be eligible as TEAM Me is an established program on the G9 Pediatrics Unit only

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive Care (TEAM Me); 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.

Other: Survey Administration; Complete survey; Other: 6 Minute Walk Functional Test; Complete 6-minute walk test; Other Names: 6MWT; SIX MINUTE WALK; SIXMW1; Behavioral: Behavioral Intervention; Participate in walking and other activities; Other Names: Behavior Conditioning Therapy; Behavior Modification; Behavior or Life Style Modifications; Behavior Therapy; Behavioral Interventions; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Behavioral Treatments; Behavioral: Timed Get Up and Go Test; Complete timed get up and go test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who enroll and complete the serial measures	Will consider the program feasible if 75% of patients approached about the study will agree to enroll and 80% of the enrolled subjects will participate in physical activity and complete the serial measures for 70% of their inpatient days until day +21. Will report the percentage with 95% confidence interval of approached patients that agree to participate at the end of the study. Each patient's percentage of days that he/she complete the serial measures until day +21 will be calculated and percentage of all patients that finish 70% of the 21 day serial measures will be estimated with 95% confidence interval.	Up to 21 days post-hematopoietic stem cell transplant (HSCT)
Incidence of adverse events.	The program will be considered tolerable if > 90% of the participants do not have any Common Terminology Criteria for Adverse Events defined adverse events that are greater than grade 2. Serious adverse event will be defined using Common Terminology Criteria for Adverse Events version 5.0 or higher.	Up to 100 days post-HSCT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6-minute walking test (6MWT)	Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT
Change in gross grip hand strength	Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT
Change in timed up and go test	Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT
Change in Borg Rating of Perceived Exertion	Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT
Change in 30 second sit-to-stand test	Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT
Change in Fitbit mileage and intensity via heart rate	Will be recorded thru their co-enrollment on MD Anderson Cancer Center protocol PA18-0130. Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT
Change in Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale	Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT
Change in PedsQL Stem Cell Transplant Model	Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT
Change in Wee Functional Independence Measure (FIM)/FIM	Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.	Baseline up to 100 days post-HSCT

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Priti Tewari, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Psychotherapy; Behavioral Disciplines and Activities; Behavior Therapy
• Other Study ID Numbers: 2020-0044 (Other Identifier: M D Anderson Cancer Center); NCI-2020-11750 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No