Study Stopped
\<75% participation
POWER UP: Participating Online While Exercising to Recover Using Play
2 other identifiers
interventional
17
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
April 4, 2022
CompletedStudy Start
First participant enrolled
May 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2025
CompletedAugust 5, 2025
July 1, 2025
3.2 years
March 15, 2022
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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)
through study completion, an average of 1 year
Study Arms (2)
Aim 1. Focus Groups
OTHERHealthcare 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:
OTHERAYAs 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
- +10 more criteria
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in Aim 1 of this study:
- Round 1 Focus Groups:
- \. 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
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keri L Schadler, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2022
First Posted
April 4, 2022
Study Start
May 4, 2022
Primary Completion
July 29, 2025
Study Completion
July 29, 2025
Last Updated
August 5, 2025
Record last verified: 2025-07