CancerPhase 2NCT05589857
A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use
A Phase 2 study testing IPAD and Augmented Reality in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cancer
- What is being tested?
- IPAD and Augmented Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 9 May 2024
- Phase
- Phase 2
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 5-15
- English and Spanish-speaking parents/legal guardians and patients
- Undergoing surgery requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
- Expected to be prescribed postoperative inpatient opioids
- Prescribed daily opioids for pain for a period equal to or longer than 30 days before surgery.
- Sufficient cognitive capacity to comprehend and interact with the game. This is defined as the ability to utilize mobile technology (use iPad with or without assistance) and activate and respond to AR experiences within the app as determined by the clinician.
- Both the child and a legal guardian are willing and able to provide informed consent.
- The range from 5-to 15 is based on a recent pilot RCT in which the PI found that older adolescents (>15 years of age) were disinterested in the interactive game.
Who cannot join
- Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
- Inability to demonstrate an understanding of the game from English instructions
- Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital
Trial locations and contacts
1 site in 1 country.
About this study
Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery.
Read the detailed description
Primary Objective:
To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of additional inpatient opioid use in pediatric cancer patients who are chronic/tolerant opioid users undergoing surgery compared to a control non-AR game in a randomized controlled trial.
Secondary Objectives:
To assess the impact of AR versus non-AR control technology in pediatric oncology patients, including:
- Inpatient opioid use
- Average daily inpatient pain score
- Number of opioid requests during hospital stay
- Inpatient PedsQL (quality of life) questionnaire score
- Ambulation/"out of bed" movement
- Number days to discharge-ready status
- Patient experience assessed by satisfaction scores on questionnaire designed by MD Anderson Cancer Center Child Life team
- Outpatient opioid use reported at 30, 60, 90 days.
- Outpatient pain scores reported at 30, 60, 90 days
- Outpatient PedsQL scores reported at 30, 60, and 90 days
- Potential adverse events related to the use of AR (i.e., falls).
- Conditions
- Cancer
- Being tested
- IPAD, Augmented Reality
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPADDevice
Participants will play a game using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world.
Augmented RealityDevice
Participants will play a game through (device camera and application) that add virtual or digital characters and items that let participants view the real world.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Spellbound) | Experimental | Participants will play SpellBound using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world. Receives: Device: IPAD |
| Group 2 (Spellbound) | Experimental | Participants will play the game using augmented reality. Receives: Device: Augmented Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Quality of Life Inventory
Quality of life assessment: Age-appropriate Pediatric Quality of Life Inventory (PedsQL)29 paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status.
Measured: through completion of study, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start25 Oct 2022
- Primary completion9 May 2024
- Study completion9 May 2024
Why it stopped: No Patients Enrolles
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juan Cata, MD, Principal investigator, MD Anderson
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589857
- Sponsor's protocol ID
- 2022-0529
- Other IDs
- NCI-2022-08945
- Status last verified
- May 2024
- First submitted
- 17 Oct 2022
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Tolerant Users Undergoing Surgery to Reduce Post-operative Opioid Use
- ClinicalTrials.gov ID
- NCT05589857
- Acronym / sponsor ID
- 2022-0529
- Conditions
- Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Patients Enrolles
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 21 Oct 2022 (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.
Tto learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients following surgery.
Detailed description
Primary Objective:
To assess the efficacy of SpellBound's AR-enabled scavenger hunt to reduce the rate of additional inpatient opioid use in pediatric cancer patients who are chronic/tolerant opioid users undergoing surgery compared to a control non-AR game in a randomized controlled trial.
Secondary Objectives:
To assess the impact of AR versus non-AR control technology in pediatric oncology patients, including:
- Inpatient opioid use
- Average daily inpatient pain score
- Number of opioid requests during hospital stay
- Inpatient PedsQL (quality of life) questionnaire score
- Ambulation/"out of bed" movement
- Number days to discharge-ready status
- Patient experience assessed by satisfaction scores on questionnaire designed by MD Anderson Cancer Center Child Life team
- Outpatient opioid use reported at 30, 60, 90 days.
- Outpatient pain scores reported at 30, 60, 90 days
- Outpatient PedsQL scores reported at 30, 60, and 90 days
- Potential adverse events related to the use of AR (i.e., falls).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Spellbound) | Experimental | Device: IPADParticipants will play SpellBound using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world. |
| Group 2 (Spellbound) | Experimental | Device: Augmented RealityParticipants will play the game using augmented reality. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Ages 5-15
- English and Spanish-speaking parents/legal guardians and patients
- Undergoing surgery requiring postoperative hospitalization is defined as ≥2 hours of duration of surgery and requiring postoperative hospital admission of at least one night
- Expected to be prescribed postoperative inpatient opioids
- Prescribed daily opioids for pain for a period equal to or longer than 30 days before surgery.
Key exclusion criteria (3 listed)
- Have never taken opioids or have had no daily opioid use within the last 30 days before surgery
- Inability to demonstrate an understanding of the game from English instructions
- Any additional concerns based on the study physicians' assessments b. Setting: Academic tertiary cancer center: University of Texas - MD Anderson Cancer Center and Baylor College of Medicine - Texas Children's Hospital
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 |
|---|---|---|
| IPADParticipants will play a game using the iPad's standard camera, which will show you your hospital room and the decal/stickers s as they appear in the real world. | Device | Group 1 (Spellbound) |
| Augmented RealityParticipants will play a game through (device camera and application) that add virtual or digital characters and items that let participants view the real world. | Device | Group 2 (Spellbound) |
Primary outcome
Pediatric Quality of Life Inventory
Time frame: through completion of study, an average of 1 year
Quality of life assessment: Age-appropriate Pediatric Quality of Life Inventory (PedsQL)29 paper surveys will be administered to the patient (self-report) or guardian (proxy) when patients reach discharge-ready status.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Cancer
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Not yet recruiting
The AYA Oncology Self-care Movement
Acute Lymphobkastic Leukemia, Medication Adherence
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
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.
Juan Cata, MD principal investigator
MD Anderson
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IPAD and Augmented Reality in people with Cancer, run by M.D. Anderson Cancer Center 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 8 inclusion and 3 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: withdrawn, as of the sponsor's last update on 23 Oct 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
Pediatric Quality of Life Inventory (time frame: through completion of study, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Oct 2024; AzTrials last refreshed its copy on 31 Oct 2026.