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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-02423 | Other Identifier | NCI-CTRP-Clinical Trial Reporting Registry |
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<75% participation
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focus Groups | Other | No intervention involved in this phase of the study |
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| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire | PROMIS 29 includes the following domains
| through study completion, an average of 1 year |
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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:
Round 2 focus groups:
In order to be eligible to participate in Aim 2 of this study, an individual must meet all of the following criteria:
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:
An individual who meets any of the following criteria will be excluded from participation in Aim 2 of this study:
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| Name | Affiliation | Role |
|---|---|---|
| Keri L Schadler, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 24, 2025 | Jul 31, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D016543 | Central Nervous System Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D017144 | Focus Groups |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Pilot randomized controlled trial |
| Other |
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. |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |