Pediatric CancerPhase 1NCT06298357
Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation
A Phase 1 study testing Immediate Start - Virtual Reality and Delayed Start - Virtual Reality in people with Pediatric Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Immediate Start - Virtual Reality and Delayed Start - Virtual Reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2024to 16 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- >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
Who cannot join
- complete blindness or deafness
- inability to operate the hand-held controllers
- susceptible to motion sickness in virtual reality
- inability to communicate in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Alabama
Birmingham, Alabama, 35233
About this study
Official title: 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).
- Conditions
- Pediatric Cancer
- Being tested
- Immediate Start - Virtual Reality, Delayed Start - Virtual Reality
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Start - Virtual RealityBehavioural
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.
Delayed Start - Virtual RealityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Start | Experimental | Program starts in the hospital and lasts for 8 weeks after hospital discharge. Receives: Behavioral: Immediate Start - Virtual Reality |
| Waitlist Control | Active comparator | After 8 weeks after hospital discharge, these participants start the 8 week intervention. Receives: Behavioral: Delayed Start - Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
Steps per day measured by a tri-axial accelerometer (Fitbit Flex).
Measured: Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9)
Secondary outcomes (3)
Minutes of gameplay
Minutes of gameplay measured by the Meta Quest headset.
Measured: 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.
Measured: 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
Measured: Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start27 Jun 2024
- Primary completion1 Dec 2025
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Lai, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298357
- Sponsor's protocol ID
- 300012601
- Other IDs
- LAIKPRI02012024
- Status last verified
- Mar 2026
- First submitted
- 29 Feb 2024
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39714090
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Gaming for Exercise and Mindfulness Among Pediatric Cancer Rehabilitation Patients: Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06298357
- Acronym / sponsor ID
- 300012601
- Conditions
- Pediatric Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Start | Experimental | Behavioral: Immediate Start - Virtual RealityProgram starts in the hospital and lasts for 8 weeks after hospital discharge. |
| Waitlist Control | Active comparator | Behavioral: Delayed Start - Virtual RealityAfter 8 weeks after hospital discharge, these participants start the 8 week intervention. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- >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
Key exclusion criteria (4 listed)
- complete blindness or deafness
- inability to operate the hand-held controllers
- susceptible to motion sickness in virtual reality
- inability to communicate in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate Start - Virtual RealityParticipants 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. | Behavioural | Immediate Start |
| Delayed Start - Virtual RealityParticipants 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. | Behavioural | Waitlist Control |
Primary outcome
Physical activity
Time frame: 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).
3 secondary outcomes
Minutes of gameplay
Time frame: Hospital discharge (approximately week 4), Intervention week 4, and Intervention Week 8.
Global Health
Time frame: 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)
Time frame: Week 0, ~Week 2 (Post-Transplant), ~Week 4 (hospital discharge), Intervention or Wait Period Week 4, Intervention or Wait Period Week 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 39714090Lai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Immediate Start - Virtual Reality and Delayed Start - Virtual Reality in people with Pediatric Cancer, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Daily, starting after consent in the hospital (week 0) and ending after the intervention (intervention week 9)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06298357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.