NCT05308407

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 4, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

May 4, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2025

Completed
Last Updated

August 5, 2025

Status Verified

July 1, 2025

Enrollment Period

3.2 years

First QC Date

March 15, 2022

Last Update Submit

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

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.

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.

Other: Pilot randomized controlled trial

Interventions

No intervention involved in this phase of the study

Aim 1. Focus Groups

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.

Aim 2. Pilot randomized controlled trial:

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Links

MeSH Terms

Conditions

Motor ActivityCentral Nervous System NeoplasmsNeoplasms

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

BehaviorNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Keri L Schadler, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

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

Locations