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Group 1(Spellbound) for Acute Lymphoblastic Leukemia

Phase 2

Recruiting

Led By Juan Cata, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of study, an average of 1 year

Awards & highlights

Study Summary

This trial is testing if a game can help young patients reduce pain and the need for opioids before surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves playing an augmented reality game rather than medication, typical drug side effects aren't expected. However, there may be non-medical concerns such as eye strain or frustration if difficulty using the app occurs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of study, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of study, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of study, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pediatric Quality of Life Inventory Questionnaires

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2 (Spellbound)Experimental Treatment1 Intervention

Participants will play the game using augmented reality

Group II: Group 1(Spellbound)Experimental Treatment1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,506,816 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,442 Total Patients Enrolled

Juan Cata, MDPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

205 Total Patients Enrolled

Media Library

Group 1(Spellbound) Clinical Trial Eligibility Overview. Trial Name: NCT05466994 — Phase 2

Acute Lymphoblastic Leukemia Research Study Groups: Group 1(Spellbound), Group 2 (Spellbound)

Acute Lymphoblastic Leukemia Clinical Trial 2023: Group 1(Spellbound) Highlights & Side Effects. Trial Name: NCT05466994 — Phase 2

Group 1(Spellbound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05466994 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research offer participation to individuals of advanced age?

"Candidates who meet the criteria of this trial should be between 5 and 15 years old. The database shows that 87 trials are available for individuals younger than 18 while 436 studies target seniors over 65."

Answered by AI

Is the application process for this experiment still ongoing?

"Clinicaltrials.gov confirms that this clinical trial is currently open for recruitment, commencing on August 19th 2022 and recently updated October 26th 2022."

Answered by AI

What risks do individuals face while undergoing this treatment?

"Power's evaluation of the safety profile for this therapy is a 2 due to ongoing Phase 2 trials, which have yielded preliminary information suggesting its security but no evidence concerning its efficacy."

Answered by AI

Are there any qualifying criteria that I must meet in order to participate in this research?

"This investigation requires 34 minors aged between 5 and 15 with neoplasms to participate. Moreover, they must also adhere to the following criteria: bilingualism in English and Spanish; scheduled for a major cancer-related surgical procedure necessitating >2 hours of surgery time coupled with an overnight hospital stay; no opioid consumption within the last month prior to their operation; adequate cognitive capacity for using mobile technology (e.g., iPad) as well as activating/responding to AR features on apps; willingness from both participant and legal guardian to sign informed consent documents. The age range was established based off research indicating that adolescents above 15 years old would not"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)

2022. "A Phase II Randomized Controlled Trial to Determine the Efficacy of an auGmented reAlity gaMe in pediatrIc caNcer Patients Who Are Opioid Naïve Undergoing Surgery to Reduce Postoperative Opioid Use (GAMING-ON Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05466994.

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