About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
6 Minute Walk Functional Test
Other interventionComplete 6-minute walk test
Behavioral Intervention
BehavioralParticipate in walking and other activities
Survey Administration
Other interventionComplete survey
Timed Get Up and Go Test
BehavioralComplete timed get up and go test
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Change in 6-minute walking test (6MWT)
Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.
Change in gross grip hand strength
Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.
Change in timed up and go test
Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.
Change in Borg Rating of Perceived Exertion
Will be estimated from descriptive statistics: mean, standard deviation, median and range for each group and be compared using Wilcoxon rank sum test when appropriate. Baseline will be defined as the initial measures conducted at time of admission. Wilcoxon signed rank test may also be applied to test any change that is significantly different from 0. Repeated measure analysis may be applied to evaluate the changes of this measure over time, correlation between this scale and the 6MWT, adjusting for other important covariates such as age, gender, weight, disease stage, performance status, etc. All testing will be 2-sided with a significance level of 0.05.
Sponsors and contacts
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