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

NCT04678427 | Recruiting

• 2 other identifiers: 2020-0044NCI-2020-11750
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Change in 6-minute walking test (6MWT)

  Baseline up to 100 days post-HSCT

• Change in gross grip hand strength

  Baseline up to 100 days post-HSCT

• Change in timed up and go test

  Baseline up to 100 days post-HSCT

• Change in Borg Rating of Perceived Exertion

  Baseline up to 100 days post-HSCT

• Change in 30 second sit-to-stand test

  Baseline up to 100 days post-HSCT

Study Arms (1)

Supportive Care (TEAM Me)

EXPERIMENTAL

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: 6 Minute Walk Functional Test; Behavioral: Behavioral Intervention; Other: Survey Administration; Behavioral: Timed Get Up and Go Test

Interventions

6 Minute Walk Functional Test OTHER

Complete 6-minute walk test

Also known as: 6MWT, SIX MINUTE WALK, SIXMW1

Supportive Care (TEAM Me)

Behavioral Intervention BEHAVIORAL

Participate in walking and other activities

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Supportive Care (TEAM Me)

Survey Administration OTHER

Complete survey

Supportive Care (TEAM Me)

Timed Get Up and Go Test BEHAVIORAL

Complete timed get up and go test

Supportive Care (TEAM Me)

Eligibility Criteria

• Age: 6 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, 75235, United States

RECRUITING

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Priti Tewari

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priti Tewari

CONTACT

713-792-6620; ptewari@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: November 13, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (2)