Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation

NCT06298357 | Completed Phase 1

• 2 other identifiers: 300012601LAIKPRI02012024
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Minutes of gameplay

  Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.

• Global Health

  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)

  Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.

Study Arms (2)

Immediate Start

EXPERIMENTAL

Program starts in the hospital and lasts for 8 weeks after hospital discharge.

Behavioral: Immediate Start - Virtual Reality

Waitlist Control

ACTIVE COMPARATOR

After 8 weeks after hospital discharge, these participants start the 8 week intervention.

Behavioral: Delayed Start - Virtual Reality

Interventions

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.

Immediate Start

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.

Waitlist Control

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Children's Hospital of Alabama

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

• 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.

  PMID: 39714090 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: June 27, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 16, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)