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

NCT ID: NCT04678427

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

6 Minute Walk Functional Test

Intervention Type OTHER

Complete 6-minute walk test

Behavioral Intervention

Intervention Type BEHAVIORAL

Participate in walking and other activities

Survey Administration

Intervention Type OTHER

Complete survey

Timed Get Up and Go Test

Intervention Type BEHAVIORAL

Complete timed get up and go test

Interventions

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6 Minute Walk Functional Test

Complete 6-minute walk test

Intervention Type OTHER

Behavioral Intervention

Participate in walking and other activities

Intervention Type BEHAVIORAL

Survey Administration

Complete survey

Intervention Type OTHER

Timed Get Up and Go Test

Complete timed get up and go test

Intervention Type BEHAVIORAL

Other Intervention Names

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6MWT SIX MINUTE WALK SIXMW1 Behavior Conditioning Therapy Behavior Modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification Behavioral Therapy Behavioral Treatment Behavioral Treatments

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Priti Tewari

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status RECRUITING

M D Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Priti Tewari

Role: CONTACT

713-792-6620

Facility Contacts

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Victor Aquino, MD

Role: primary

214-730-5437

Priti Tewari

Role: primary

713-792-6620

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

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NCI-2020-11750

Identifier Type: REGISTRY

Identifier Source: secondary_id

2020-0044

Identifier Type: OTHER

Identifier Source: secondary_id

2020-0044

Identifier Type: -

Identifier Source: org_study_id

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