Hematopoietic and Lymphoid Cell NeoplasmNCT04678427
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
A study testing 6 Minute Walk Functional Test, Behavioral Intervention and Survey Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 29 years
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- 6 Minute Walk Functional Test, Behavioral Intervention and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2020to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75235
M D Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: TEAM Me (Totally Excited About Moving, Mobility, and Exercise) Clinical Research Protocol
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Being tested
- 6 Minute Walk Functional Test, Behavioral Intervention, Survey Administration, Timed Get Up and Go Test
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 Minute Walk Functional TestOther
Also called 6MWT, SIX MINUTE WALK, SIXMW1
Complete 6-minute walk test
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in walking and other activities
Survey AdministrationOther
Complete survey
Timed Get Up and Go TestBehavioural
Complete timed get up and go test
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (TEAM Me) | Experimental | 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. Receives: Other: 6 Minute Walk Functional Test; Behavioral: Behavioral Intervention; Other: Survey Administration; Behavioral: Timed Get Up and Go Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 100 days post-HSCT
Secondary outcomes (9)
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.
Measured: Baseline up to 100 days post-HSCT
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.
Measured: Baseline up to 100 days post-HSCT
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.
Measured: Baseline up to 100 days post-HSCT
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.
Measured: Baseline up to 100 days post-HSCT
Change in 30 second sit-to-stand 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.
Measured: Baseline up to 100 days post-HSCT
Change in Fitbit mileage and intensity via heart rate
Will be recorded thru their co-enrollment on MD Anderson Cancer Center protocol PA18-0130. 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.
Measured: Baseline up to 100 days post-HSCT
Change in Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
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.
Measured: Baseline up to 100 days post-HSCT
Change in PedsQL Stem Cell Transplant Model
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.
Measured: Baseline up to 100 days post-HSCT
Change in Wee Functional Independence Measure (FIM)/FIM
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.
Measured: Baseline up to 100 days post-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start13 Nov 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priti Tewari, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04678427
- Sponsor's protocol ID
- 2020-0044
- Other IDs
- NCI-2020-11750, 2020-0044
- Status last verified
- Oct 2026
- First submitted
- 16 Dec 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TEAM Me (Totally Excited About Moving, Mobility, and Exercise) Clinical Research Protocol
- ClinicalTrials.gov ID
- NCT04678427
- Acronym / sponsor ID
- 2020-0044
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (TEAM Me) | Experimental | Other: 6 Minute Walk Functional Test, Behavioral: Behavioral Intervention, Other: Survey Administration, Behavioral: Timed Get Up and Go TestPatients 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. |
Who may qualify
- Ages
- 6 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 Minute Walk Functional TestAlso: 6MWT, SIX MINUTE WALK, SIXMW1Complete 6-minute walk test | Other | Supportive Care (TEAM Me) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior TherapyParticipate in walking and other activities | Behavioural | Supportive Care (TEAM Me) |
| Survey AdministrationComplete survey | Other | Supportive Care (TEAM Me) |
| Timed Get Up and Go TestComplete timed get up and go test | Behavioural | Supportive Care (TEAM Me) |
Primary outcome
Proportion of patients who enroll and complete the serial measures
Time frame: 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.
Time frame: 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priti Tewari principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 Minute Walk Functional Test, Behavioral Intervention and Survey Administration in people with Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who enroll and complete the serial measures (time frame: Up to 21 days post-hematopoietic stem cell transplant (HSCT)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.