Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation

Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation Patients: Pilot Randomized Controlled Trial

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Cancer
• Intervention / Treatment: Behavioral: Immediate Start - Virtual Reality; Behavioral: Delayed Start - Virtual Reality

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Byron Lai, PhD; Phone Number: 8-9725 205.638.9790; Email: blai@uabmc.edu
• Study Contact Backup: Name: Raven Young, BS; Email: ravensamuel@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Children's Hospital of Alabama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• >7 years of age
• medical diagnosis of malignancy or non-malignant condition requiring hematopoietic stem cell transplant
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Start; Program starts in the hospital and lasts for 8 weeks after hospital discharge.	Behavioral: Immediate Start - Virtual Reality; 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.
Active Comparator: Waitlist Control; After 8 weeks after hospital discharge, these participants start the 8 week intervention.	Behavioral: Delayed Start - Virtual Reality; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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.

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: February 29, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 300012601; LAIKPRI02012024 (Other Grant/Funding Number: Kaul Pediatric Research Institute Pilot Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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