TEAM Me (Totally Excited About Moving, Mobility, and Exercise) Clinical Research Protocol
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.
Arms & interventions
- Other6 Minute Walk Functional Test
Complete 6-minute walk test
- BehavioralBehavioral Intervention
Participate in walking and other activities
- OtherSurvey Administration
Complete survey
- BehavioralTimed Get Up and Go Test
Complete timed get up and go test
Outcome measures
Primary
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.
Time frame: 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.
Time frame: Up to 100 days post-HSCT
Secondary
Change in 6-minute walking test (6MWT)
Time frame: Baseline up to 100 days post-HSCT
Change in gross grip hand strength
Time frame: Baseline up to 100 days post-HSCT
Change in timed up and go test
Time frame: Baseline up to 100 days post-HSCT
Change in Borg Rating of Perceived Exertion
Time frame: Baseline up to 100 days post-HSCT
Change in 30 second sit-to-stand test
Time frame: Baseline up to 100 days post-HSCT
Change in Fitbit mileage and intensity via heart rate
Time frame: Baseline up to 100 days post-HSCT
Change in Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Time frame: Baseline up to 100 days post-HSCT
Change in PedsQL Stem Cell Transplant Model
Time frame: Baseline up to 100 days post-HSCT
Change in Wee Functional Independence Measure (FIM)/FIM
Time frame: Baseline up to 100 days post-HSCT
Eligibility criteria
Study locations (2)
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75235
M D Anderson Cancer Center
Houston, Texas, 77030