Clinical trial NCT05308407: POWER UP: Participating Online While Exercising to Recover Using Play
Official title: POWER UP: Participating Online While Exercising to Recover Using Play
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Exercise
Central Nervous System Tumors
Tumors
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Life Questionnaire
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Keri L Schadler, MD
role: PRINCIPAL_INVESTIGATOR
References: