POWER UP: Participating Online While Exercising to Recover Using Play

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.

Study Overview

• Status: Suspended
• Conditions: Exercise; Central Nervous System Tumors; Tumors
• Intervention / Treatment: Other: Focus Groups; Other: Pilot randomized controlled trial

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Swartz, MD; Phone Number: 713-745-3763; Email: mchang1@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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:

1. Oncologists who are caring for AYA cancer survivors or
2. Survivorship care providers who actively engage with AYA cancer survivors

Round 2 focus groups:

1. AYA cancer survivors age 15-39 years old
2. 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
3. ≤1-year post surgery and can have other tumor-directed treatment (e.g., radiation and/or chemotherapy)
4. Participants and/or guardians are willing and able to provide informed consent
5. Able to speak, read, and understand English
6. Daily access to the web
7. 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:

1. Age 15-39 years old
2. 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
3. ≤1-year post surgery and can have other tumor-directed treatment (e.g., radiation and/or chemotherapy)
4. Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week)
5. Able to speak, read, and understand English
6. Daily access to the web
7. Approval to participate from the oncology care team
8. Participants and/or guardians are willing and able to provide informed consent
9. Able to move arms and legs as well as ambulate safely with and without a gait aid
10. Available space on the smartphone to download required apps
11. Can receive physical therapy because this is part of the standard of care
12. 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.

Exclusion Criteria

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:

1. Another member of the household is a participant or staff member on this trial
2. Do not have access to the internet
3. In foster care or is incarcerated
4. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
5. 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:

1. Currently pregnant
2. Currently have dementia
3. 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
4. Clinical judgment by the oncology care team concerning safety based on the Physical Activity Readiness Questionnaire for Everyone (2020 PAR-Q+)
5. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
6. Self-reported diagnosis of a metastatic CNS tumor or confirmed diagnosis of a metastatic CNS tumor radiographically or pathologically when available
7. Currently participating in an organized commercial or research-based exercise program
8. Another member of the household is a participant or staff member on this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Aim 1. Focus Groups; 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; No intervention involved in this phase of the study
Other: Aim 2. Pilot randomized controlled trial: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Maria Swartz, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Nervous System Neoplasms; Central Nervous System Neoplasms
• Other Study ID Numbers: 2021-0887; NCI-2022-02423 (Other Identifier: NCI-CTRP-Clinical Trial Reporting Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No