Recruiting

TEAM Me

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04678427

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 6 - 29

Healthy Volunteers: Not accepted

Interventions

6 Minute Walk Functional Test

Behavioral Intervention

Survey Administration

Timed Get Up and Go Test

Study Details

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

Study ID

NCT04678427

Start date

Nov 13, 2020

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 29

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

6 Minute Walk Functional Test

Complete 6-minute walk test

Behavioral Intervention

Participate in walking and other activities

Survey Administration

Complete survey

Timed Get Up and Go Test

Complete timed get up and go test

Primary outcome measure

  • Proportion of patients who enroll and complete the serial measures [ Time Frame: Up to 21 days post-hematopoietic stem cell transplant (HSCT) ]
  • Incidence of adverse events. [ Time Frame: Up to 100 days post-HSCT ]

Central Contacts and Locations

Central contacts

Priti Tewari

713-792-6620ptewari@mdanderson.org

Locations

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75235

Contacts

Victor Aquino, MD

214-730-5437Victor.Aquino@UTSouthwestern.edu

Principal Investigator:

Victor Aquino, MD

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Priti Tewari

713-792-6620

Principal Investigator:

Priti Tewari

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 4, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-04.