TEAM Me (Totally Excited About Moving, Mobility, and Exercise) Clinical Research Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Proportion of patients who enroll and complete the serial measures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 29 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: 6 Minute Walk Functional Test (Other)
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.
干预措施: Behavioral Intervention (Behavioral)
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.
干预措施: Survey Administration (Other)
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.
干预措施: Timed Get Up and Go Test (Behavioral)
结局指标
主要结局
Proportion of patients who enroll and complete the serial measures
时间窗: Up to 21 days post-hematopoietic stem cell transplant (HSCT)
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.
时间窗: Up to 100 days post-HSCT
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.
次要结局
- Change in gross grip hand strength(Baseline up to 100 days post-HSCT)
- Change in timed up and go test(Baseline up to 100 days post-HSCT)
- Change in PedsQL Stem Cell Transplant Model(Baseline up to 100 days post-HSCT)
- Change in 6-minute walking test (6MWT)(Baseline up to 100 days post-HSCT)
- Change in 30 second sit-to-stand test(Baseline up to 100 days post-HSCT)
- Change in Fitbit mileage and intensity via heart rate(Baseline up to 100 days post-HSCT)
- Change in Borg Rating of Perceived Exertion(Baseline up to 100 days post-HSCT)
- Change in Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale(Baseline up to 100 days post-HSCT)
- Change in Wee Functional Independence Measure (FIM)/FIM(Baseline up to 100 days post-HSCT)