ExerciseNCT05308407
POWER UP: Participating Online While Exercising to Recover Using Play
A study testing Focus Groups in people with Exercise and Central Nervous System Tumors, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
We will conduct a two-phase study. The first phase is to adapt and develop an active video game (AVG)-centered lifestyle physical activity (PA) intervention (POWER UP) for adolescents and young adults (AYA) with central nervous system tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise, Central Nervous System Tumors, Tumors
- What is being tested?
- Focus Groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2022to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to be eligible to participate in Aim 1 of this study, an individual must meet all of the following criteria:
- Round 1 focus groups:
- Oncologists who are caring for AYA cancer survivors or
- Survivorship care providers who actively engage with AYA cancer survivors
- Round 2 focus groups:
- AYA cancer survivors age 15-39 years old
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- Self-reported diagnosis of a primary benign or malignant CNS tumor or confirmed diagnosis of primary benign or malignant CNS tumor radiographically or pathologically when available
- ≤1-year post surgery and can have other tumor-directed treatment (e.g., radiation and/or chemotherapy)
- Participants and/or guardians are willing and able to provide informed consent
- Able to speak, read, and understand English
- Daily access to the web
- Can receive physical therapy because this is part of the standard of care
- In order to be eligible to participate in Aim 2 of this study, an individual must meet all of the following criteria:
- Age 15-39 years old
- Self-reported diagnosis of a primary benign or malignant CNS tumor or confirmed diagnosis of primary benign or malignant CNS tumor radiographically or pathologically when available
- ≤1-year post surgery and can have other tumor-directed treatment (e.g., radiation and/or chemotherapy)
- Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week)
- Able to speak, read, and understand English
- Daily access to the web
- Approval to participate from the oncology care team
- Participants and/or guardians are willing and able to provide informed consent
- Able to move arms and legs as well as ambulate safely with and without a gait aid
- Available space on the smartphone to download required apps
- Can receive physical therapy because this is part of the standard of care
- Participants and/or guardians are willing and able to provide informed consent for protocol PA18-0130 (Pediatric Energy Balance Data Repository Study), companion protocol for the Fitbit application/assessment.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in Aim 1 of this study:
- Round 1 Focus Groups:
- 1. Do not have access to the internet
- Round 2 Focus Groups:
- Another member of the household is a participant or staff member on this trial
- Do not have access to the internet
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- In foster care or is incarcerated
- Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
- Self-reported diagnosis of a metastatic CNS tumor or confirmed diagnosis of a metastatic CNS tumor radiographically or pathologically when available
- An individual who meets any of the following criteria will be excluded from participation in Aim 2 of this study:
- Currently pregnant
- Currently have dementia
- Plans to travel for more than 2 weeks at a time during the study period where the participant is not able to sign in to join the videoconferencing sessions
- Clinical judgment by the oncology care team concerning safety based on the Physical Activity Readiness Questionnaire for Everyone (2020 PAR-Q+)
- Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
- Self-reported diagnosis of a metastatic CNS tumor or confirmed diagnosis of a metastatic CNS tumor radiographically or pathologically when available
- Currently participating in an organized commercial or research-based exercise program
- Another member of the household is a participant or staff member on this trial
Trial locations and contacts
1 site in 1 country.
About this study
We will conduct a two-phase study. The first phase is to adapt and develop an active video game (AVG)-centered lifestyle physical activity (PA) intervention (POWER UP) for adolescents and young adults (AYA) with central nervous system tumors. The second phase is to test the feasibility and preliminary efficacy of a 12-week virtually delivered, group-based active video game-centered lifestyle physical activity intervention on function and quality of life in AYAs (aged 15-39) who are ≤1-year post-surgery for a central nervous system tumor. This population is at very high-risk for steep functional decline.
Read the detailed description
Objective:
To develop (Aim 1) and test (Aim2, Primary Objective) the feasibility and acceptability of a virtually delivered, group-based active video game-centered lifestyle physical activity intervention targeting affect to improve function and quality of life in insufficiently active AYAs with central nervous system tumors. Also, (Aim 2, Secondary Objective) in a pilot randomized trial, compare the physical function, quality of live, and physical activity level between intervention and control groups.
Primary: Feasibility and acceptability of the POWER UP intervention and assessments.
Secondary: Physical function, quality of life (QOL), symptoms, and PA levels as measured at the 12- and 24-week follow ups
. Other endpoints relevant to the primary and secondary objectives: BMI status, dietary intake, Fitbit data (days worn and steps), exercise motivation, basic psychological needs at the 12- and 24-week follow-ups
- Conditions
- Exercise, Central Nervous System Tumors, Tumors
- Being tested
- Focus Groups, Pilot randomized controlled trial
- Medical subject headings
- Motor Activity, Central Nervous System Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupsOther
No intervention involved in this phase of the study
Pilot randomized controlled trialOther
The intervention is a virtually delivered, 12 weekly group-based active video game-centered lifestyle physical activity intervention (POWER UP) targeting affect to improve function and quality of life in insufficiently active AYAs with central nervous system tumors.
| Study group | Role | What they receive |
|---|---|---|
| Aim 1. Focus Groups | Other | Healthcare providers (n=16-24 participants in 4 focus groups) from MD Anderson Cancer Center (MDACC).
AYAs with primary benign or malignant central nervous system tumors (n=16-24 participants in 4 focus groups) treated at MDACC. Receives: Other: Focus Groups |
| Aim 2. Pilot randomized controlled trial: | Other | AYAs with primary benign or malignant central nervous system tumors (n=80 patients approached, with n= 40 participants consented and randomized to the intervention (n=20) or usual care control group (n=20)) treated at MDACC, any gender and race, who are ≤1-year post-surgery for a central nervous system tumor. Receives: Other: Pilot randomized controlled trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Questionnaire
PROMIS 29 includes the following domains
- Physical Function (5=without any difficulty, 1=unable to do)
- Anxiety (5=always, 1=never)
- Depression (5=always, 1=never)
- Fatigue (5=very much, 1=not at all)
- Sleep Disturbance (5=very poor, 1=very good)
- Ability to participate in Social Roles and Activities(5=never, 1=always)
- Pain Interference (5=very much, 1=not at all)
- Pain Intensity (10=worst pain imaginable, 0=no pain)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start4 May 2022
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keri L Schadler, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308407
- Sponsor's protocol ID
- 2021-0887
- Other IDs
- NCI-2022-02423
- Status last verified
- Jul 2025
- First submitted
- 15 Mar 2022
- Last updated
- 5 Aug 2025
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- POWER UP: Participating Online While Exercising to Recover Using Play
- ClinicalTrials.gov ID
- NCT05308407
- Acronym / sponsor ID
- 2021-0887
- Conditions
- Exercise, Central Nervous System Tumors, Tumors
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 17 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 4 Apr 2022 (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.
We will conduct a two-phase study. The first phase is to adapt and develop an active video game (AVG)-centered lifestyle physical activity (PA) intervention (POWER UP) for adolescents and young adults (AYA) with central nervous system tumors. The second phase is to test the feasibility and preliminary efficacy of a 12-week virtually delivered, group-based active video game-centered lifestyle physical activity intervention on function and quality of life in AYAs (aged 15-39) who are ≤1-year post-surgery for a central nervous system tumor. This population is at very high-risk for steep functional decline.
Detailed description
Objective:
To develop (Aim 1) and test (Aim2, Primary Objective) the feasibility and acceptability of a virtually delivered, group-based active video game-centered lifestyle physical activity intervention targeting affect to improve function and quality of life in insufficiently active AYAs with central nervous system tumors. Also, (Aim 2, Secondary Objective) in a pilot randomized trial, compare the physical function, quality of live, and physical activity level between intervention and control groups.
Primary: Feasibility and acceptability of the POWER UP intervention and assessments.
Secondary: Physical function, quality of life (QOL), symptoms, and PA levels as measured at the 12- and 24-week follow ups
. Other endpoints relevant to the primary and secondary objectives: BMI status, dietary intake, Fitbit data (days worn and steps), exercise motivation, basic psychological needs at the 12- and 24-week follow-ups
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aim 1. Focus Groups | Other | Other: Focus GroupsHealthcare providers (n=16-24 participants in 4 focus groups) from MD Anderson Cancer Center (MDACC). AYAs with primary benign or malignant central nervous system tumors (n=16-24 participants in 4 focus groups) treated at MDACC. |
| Aim 2. Pilot randomized controlled trial: | Other | Other: Pilot randomized controlled trialAYAs with primary benign or malignant central nervous system tumors (n=80 patients approached, with n= 40 participants consented and randomized to the intervention (n=20) or usual care control group (n=20)) treated at MDACC, any gender and race, who are ≤1-year post-surgery for a central nervous system tumor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- In order to be eligible to participate in Aim 1 of this study, an individual must meet all of the following criteria:
- Oncologists who are caring for AYA cancer survivors or
- Survivorship care providers who actively engage with AYA cancer survivors
- AYA cancer survivors age 15-39 years old
- Self-reported diagnosis of a primary benign or malignant CNS tumor or confirmed diagnosis of primary benign or malignant CNS tumor radiographically or pathologically when available
Key exclusion criteria (18 listed)
- An individual who meets any of the following criteria will be excluded from participation in Aim 1 of this study:
- 1. Do not have access to the internet
- Another member of the household is a participant or staff member on this trial
- Do not have access to the internet
- In foster care or is incarcerated
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 |
|---|---|---|
| Focus GroupsNo intervention involved in this phase of the study | Other | Aim 1. Focus Groups |
| Pilot randomized controlled trialThe intervention is a virtually delivered, 12 weekly group-based active video game-centered lifestyle physical activity intervention (POWER UP) targeting affect to improve function and quality of life in insufficiently active AYAs with central nervous system tumors. | Other | Aim 2. Pilot randomized controlled trial: |
Primary outcome
Quality of Life Questionnaire
Time frame: through study completion, an average of 1 year
PROMIS 29 includes the following domains * Physical Function (5=without any difficulty, 1=unable to do) * Anxiety (5=always, 1=never) * Depression (5=always, 1=never) * Fatigue (5=very much, 1=not at all) * Sleep Disturbance (5=very poor, 1=very good) * Ability to participate in Social Roles and Activities(5=never, 1=always) * Pain Interference (5=very much, 1=not at all) * Pain Intensity (10=worst pain imaginable, 0=no pain)
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- M D Anderson Cancer CenterLink 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.
Keri L Schadler, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focus Groups in people with Exercise and Central Nervous System Tumors, run by M.D. Anderson Cancer Center at 1 site 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 25 inclusion and 18 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: stopped early, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
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?
Quality of Life Questionnaire (time frame: through study completion, an average of 1 year). 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 5 Aug 2025.