Clinical trial NCT04678427: 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
Official title: TEAM Me (Totally Excited About Moving, Mobility, and Exercise) Clinical Research Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who enroll and complete the serial measures
timeFrame: Up to 21 days post-hematopoietic stem cell transplant (HSCT)
measure: Incidence of adverse events.
timeFrame: Up to 100 days post-HSCT
Secondary outcomes:
measure: Change in 6-minute walking test (6MWT)
timeFrame: Baseline up to 100 days post-HSCT
measure: Change in gross grip hand strength
timeFrame: Baseline up to 100 days post-HSCT
measure: Change in timed up and go test
timeFrame: Baseline up to 100 days post-HSCT
measure: Change in Borg Rating of Perceived Exertion
timeFrame: Baseline up to 100 days post-HSCT
measure: Change in 30 second sit-to-stand test
timeFrame: Baseline up to 100 days post-HSCT
measure: Change in Fitbit mileage and intensity via heart rate
timeFrame: Baseline up to 100 days post-HSCT
measure: Change in Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
timeFrame: Baseline up to 100 days post-HSCT
measure: Change in PedsQL Stem Cell Transplant Model
timeFrame: Baseline up to 100 days post-HSCT
measure: Change in Wee Functional Independence Measure (FIM)/FIM
timeFrame: Baseline up to 100 days post-HSCT
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Priti Tewari
role: PRINCIPAL_INVESTIGATOR
References: