Augmented Reality Game for Pediatric Cancer

Recruiting at 1 trial location

Overseen By Juan Cata, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Opioids

Disqualifiers: Peripheral neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: 90 days

29 Participants Needed

Trial Summary

What is the purpose of this trial?

To learn if playing an augmented reality game called SpellBound can reduce pain and the need for opioids in young patients scheduled for surgery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that participants have not used opioids daily in the last 30 days before surgery.

What data supports the effectiveness of the treatment Augmented Reality Game (SpellBound) for pediatric cancer?

Research shows that digital games, including virtual reality and active video games, can help manage cancer by reducing pain, anxiety, and fatigue, and improving physical activity and motor skills in children with cancer. These findings suggest that similar technologies, like augmented reality games, may also be beneficial for pediatric cancer patients. ^{1 2 3 4 5}

Is the Augmented Reality Game (SpellBound) safe for children?

The available research does not provide specific safety data for the Augmented Reality Game (SpellBound) in children with cancer or other conditions. However, a similar multimedia mixed reality game for children with atopic dermatitis showed acceptable usability and no significant safety concerns in a small study. ^{6 7 8 9 10}

How does the Augmented Reality Game for Pediatric Cancer differ from other treatments for this condition?

This treatment is unique because it uses an augmented reality game to combine physical exercise with empowerment, aiming to improve both the physical and psychological quality of life for children with cancer. Unlike traditional treatments that focus solely on medical interventions, this approach integrates digital empowerment to enhance resilience and understanding of the disease. ^{1 11 12 13 14}

Research Team

Juan Cata, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for children aged 5-15 with cancer, scheduled for major surgery requiring at least one night's hospital stay. They must be opioid-naïve, able to understand and interact with an iPad game, and have parents/guardians who can consent. Children over 15 or those with prior neuropathy or recent opioid use are excluded.

Inclusion Criteria

Both the child and a legal guardian are willing and able to provide informed consent.

I am expected to need strong painkillers after surgery.

I am scheduled for a major cancer surgery that requires staying in the hospital overnight.

Exclusion Criteria

Inability to demonstrate an understanding of the game from English instructions

Patients with any daily opioid use within 30 days before surgery.

Any additional concerns based on the study physicians' assessments

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants play the SpellBound augmented reality game to assess its efficacy in reducing postoperative opioid use

90 days

Inpatient stay with daily monitoring

Follow-up

Participants are monitored for outpatient opioid consumption and pain scores at 30, 60, and 90 days

3 months

Outpatient assessments at 30, 60, and 90 days

Long-term follow-up

Quality of life and adverse events related to AR use are assessed

1 year

Treatment Details

Interventions

• Augmented Reality Game (SpellBound)

Trial Overview The study tests if a SpellBound augmented reality game on an iPad can help reduce pain and lessen the need for opioids in pediatric patients after surgery. It's a randomized controlled trial comparing game interaction outcomes against standard postoperative care.

Participant Groups

Group I: Group 2 (Spellbound) Experimental Treatment 1 Intervention

Participants will play the game using augmented reality

Group II: Group 1(Spellbound) Experimental Treatment 1 Intervention

Participants will play the game using the iPad's standard camera, which will show you your hospital room and the decals as they appear in the real world.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A systematic review of six randomized controlled trials involving 379 pediatric cancer patients found that virtual reality (VR) significantly reduces pain, anxiety, and fear symptoms, indicating its efficacy as a supportive treatment.

The results showed a notable decrease in pain (mean difference of -4.82), anxiety (standardized mean difference of -1.47), and fear (mean difference of -1.25) when using VR, suggesting it can be a valuable tool in managing the psychological and physical discomfort of young cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. Cheng, Z., Yu, S., Zhang, W., et al.[2022]

A study involving 257 children and adolescents with leukemia and lymphoma revealed that fatigue was the most severe adverse event reported both before and after treatment, affecting 68.1% of participants at the start and 67% after treatment.

Gastrointestinal symptoms, such as nausea and abdominal pain, were also prevalent, with little change in severity or interference over time, indicating that despite supportive care, many children continue to experience significant symptoms during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal use of patient reported outcomes in pediatric leukemia and lymphoma reveals clinically relevant symptomatic adverse events. Jacobs, SS., Withycombe, JS., Castellino, SM., et al.[2022]

The study highlights the importance of accurately reporting infectious adverse events (AEs) in children with acute lymphoblastic leukemia (ALL) to better manage safety and toxicity during clinical trials.

Key processes implemented in two phase III trials included targeted toxicity identification, specific case report forms for infections, and real-time physician review, which have shown preliminary improvements in the reporting of infectious AEs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group. Elgarten, CW., Thompson, JC., Angiolillo, A., et al.[2023]

From 2008 to 2012, the FDA recorded 113,077 adverse drug reactions (ADRs) in pediatric patients, with the majority of reports coming from medical doctors (32%) and consumers (26%).

The most commonly reported ADRs included pyrexia, convulsions, vomiting, and accidental overdoses, particularly associated with drugs affecting the nervous system and antineoplastic/immunomodulating agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System Database of the Food and Drug Administration. Bigi, C., Tuccori, M., Bocci, G.[2022]

A game-based symptom-reporting app was used by 19 school-age children with cancer, showing preliminary feasibility with a median usage of 4 days, and high engagement with features like symptom reporting and drawing.

Both children and parents found the app acceptable, appreciating its interactive nature and the opportunity for children to express their symptoms creatively, suggesting it could enhance autonomy and decision-making in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a game-based symptom-reporting app for children with cancer: perspectives of children and parents. Linder, LA., Newman, AR., Stegenga, K., et al.[2023]

Active video gaming (AVG) was found to be a feasible and enjoyable way to promote regular physical exercise in children aged 7-17 who are survivors of brain tumors, with participants engaging in AVG for an average of 47 minutes on 72% of days.

The study showed a significant improvement in Body Coordination scores by 15% after 10-12 weeks of AVG, indicating that this intervention can enhance physical functioning in childhood brain tumor survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Active video gaming improves body coordination in survivors of childhood brain tumours. Sabel, M., Sjölund, A., Broeren, J., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Prototype Exercise-Empowerment Mobile Video Game for Children With Cancer, and Its Usability Assessment: Developing Digital Empowerment Interventions for Pediatric Diseases. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Virtual reality for pain and anxiety of pediatric oncology patients: A systematic review and meta-analysis. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

A review of mobile applications to help adolescent and young adult cancer patients. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Digital games as an effective approach for cancer management: Opportunities and challenges. [2020]

5. England pubmed.ncbi.nlm.nih.gov

The effect of an active video game intervention on physical activity, motor performance, and fatigue in children with cancer: a randomized controlled trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Longitudinal use of patient reported outcomes in pediatric leukemia and lymphoma reveals clinically relevant symptomatic adverse events. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Multimedia Mixed Reality Interactive Shared Decision-Making Game in Children with Moderate to Severe Atopic Dermatitis, a Pilot Study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Preventable harm because of outpatient medication errors among children with leukemia and lymphoma: A multisite longitudinal assessment. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Improving infectious adverse event reporting for children and adolescents enrolled in clinical trials for acute lymphoblastic leukemia: A report from the Children's Oncology Group. [2023]

10. Italy pubmed.ncbi.nlm.nih.gov

Healthcare professionals and pharmacovigilance of pediatric adverse drug reactions: a 5-year analysis of Adverse Events Reporting System Database of the Food and Drug Administration. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

HabitApp: New Play Technologies in Pediatric Cancer to Improve the Psychosocial State of Patients and Caregivers. [2020]

12. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a game-based symptom-reporting app for children with cancer: perspectives of children and parents. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Care at Your Fingertips: Codesign, Development, and Evaluation of the Oncology Hub App for Remote Symptom Management in Pediatric Oncology. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Active video gaming improves body coordination in survivors of childhood brain tumours. [2022]