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| ID | Type | Description | Link |
|---|---|---|---|
| LAIKPRI02012024 | Other Grant/Funding Number | Kaul Pediatric Research Institute Pilot Grant |
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This study will explore the potential benefits of a virtual reality gaming program that focuses on mindfulness and exercise among pediatric cancer rehabilitation patients. The program will last 8 weeks outside of the hospital. Participants will start immediately in the hospital (immediate start group) or wait 8 weeks after hospital discharge to start the program (waitlist control group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Start | Experimental | Program starts in the hospital and lasts for 8 weeks after hospital discharge. |
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| Waitlist Control | Active Comparator | After 8 weeks after hospital discharge, these participants start the 8 week intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Start - Virtual Reality | Behavioral | Participants will use a Meta Quest virtual reality headset and play video games for exercise and mindfulness. They will start using the headsets in the hospital and then will continue to do so for 8 weeks after hospital discharge. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | Steps per day measured by a tri-axial accelerometer (Fitbit Flex). | Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Minutes of gameplay | Minutes of gameplay measured by the Meta Quest headset. | Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8. |
| Global Health | National Institutes of Health (NIH) PROMIS Global Health Short Form 7+2 survey. The scale consists of 7 items that are summarized into a single score of overall health. Participants respond to items without a recall period on how they would rate their overall health, quality of life, and their physical, mental, and social health, using a 5-point Likert scale with varying response categories. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39714090 | Derived | Lai B, Chaviano K, Richman JS, Ahmad M, Wright A, Young R, Davis D, Rimmer JH, Madan-Swain A, Chewning JH. Extended Reality Gaming for Exercise and Mindfulness Throughout Pediatric Cancer Rehabilitation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Dec 23;13:e64879. doi: 10.2196/64879. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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There will be 2 parallel groups, immediate start group and waitlist control group. Once control participants finish the wait period (8 weeks), they will start the intervention (8 weeks). Participants in the immediate start group will start exercise and mindfulness in the hospital and continue the program for 8 weeks outside of the hospital.
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| Delayed Start - Virtual Reality | Behavioral | Participants will receive usual care in the hospital and outside of the hospital for 8 weeks. After the 8 week post-discharge period, participants will use a Meta Quest virtual reality headset and play video games for exercise and mindfulness for an 8 week period. |
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| Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8. |
| Forced Expiratory Volume in the first second (FEV1) | FEV1 (Liters) by a Spirometer | Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8. |