Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation

Phase 1

Recruiting

• Conditions: Pediatric Cancer
• Interventions: Behavioral: Immediate Start - Virtual Reality; Behavioral: Delayed Start - Virtual Reality

• Registration Number: NCT06298357
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-29
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-07
• Study Start: 2024-06-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-02
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• >7 years of age
• medical diagnosis of malignancy or non-malignant condition requiring hematopoietic stem cell transplant or a hospital stay that is anticipated to last for at least 2 weeks
• a caregiver who can assist the child with the study procedures

Exclusion Criteria

• complete blindness or deafness
• inability to operate the hand-held controllers
• susceptible to motion sickness in virtual reality
• inability to communicate in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate Start	Immediate Start - Virtual Reality	Program starts in the hospital and lasts for 8 weeks after hospital discharge.
Waitlist Control	Delayed Start - Virtual Reality	After 8 weeks after hospital discharge, these participants start the 8 week intervention.

Primary Outcome Measures

Name	Time	Method
Physical activity	Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9)	Steps per day measured by a tri-axial accelerometer (Fitbit Flex).

Secondary Outcome Measures

Name	Time	Method
Minutes of gameplay	Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.	Minutes of gameplay measured by the Meta Quest headset.
Global Health	Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.	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.
Forced Expiratory Volume in the first second (FEV1)	Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.	FEV1 (Liters) by a Spirometer

Trial Locations

Locations (1)

Children's Hospital of Alabama; 🇺🇸 Birmingham, Alabama, United States