Virtual Reality Tool for Cancer

Overseen By Vidya Puthepura, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Chemotherapy

Disqualifiers: Head wounds, Seizures, others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual reality tool called Life at 100.4, designed to help kids with cancer and their caregivers understand what to do if they get a fever. The tool educates about fever and neutropenia (a condition with low levels of white blood cells, increasing infection risk) and guides when to seek medical help. Participants will join focus groups and beta test the VR tool to assess its ease of use and helpfulness. This study targets newly diagnosed patients with cancer or bone marrow failure, who are starting chemotherapy and have a central line. As an unphased trial, it offers a unique opportunity to contribute to the development of innovative educational tools that could benefit future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this virtual reality tool is safe for patients and caregivers?

Research has shown that Life at 100.4 is a virtual reality tool designed to help young cancer patients and their caregivers understand febrile neutropenia, a condition characterized by fever and a low white blood cell count, which can be serious.

While specific safety data from these studies is not available, virtual reality tools like Life at 100.4 are generally considered safe because they do not involve medication or physical procedures. Therefore, participants will not experience typical drug trial side effects such as nausea or fatigue.

Virtual reality experiences can sometimes cause mild discomforts like dizziness or headaches, but these effects usually subside quickly. Life at 100.4 is in a research phase labeled "Not Applicable," focusing on assessing its practicality and acceptability rather than identifying side effects. This suggests the tool poses a low risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Reality Tool for Cancer because it offers a fresh approach to patient education and self-care. Unlike traditional methods that rely on brochures or in-person consultations, this trial uses a VR-based educational intervention called "Life at 100.4" to help patients understand and manage fever with neutropenia. The immersive experience is designed to improve patients' comprehension of when and how to check for fever and what actions to take, potentially reducing hospital visits and enhancing patient autonomy. By leveraging technology, this trial aims to make learning more engaging and effective for cancer patients.

What evidence suggests that the Life at 100.4 virtual reality tool is effective for cancer education?

Research has shown that the Life at 100.4 virtual reality tool helps cancer patients and their caregivers understand febrile neutropenia, a condition where a fever occurs with low white blood cell counts. This tool teaches users to identify and respond to these fevers, which is crucial for timely medical care. Effective educational tools like this have reduced complications by improving understanding of medical conditions. In this trial, participants will engage in beta testing of the Life at 100.4 tool to assess its effectiveness. Although specific data on Life at 100.4's effectiveness is limited, similar VR-based educational tools have shown promising results in teaching users and reducing health risks. The innovative approach of Life at 100.4 suggests it could significantly impact patient education. ^{1 2 3 5 6}

Who Is on the Research Team?

Asher Marks, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for young cancer patients and their caregivers at Yale Pediatric Hematology and Oncology who have recently been diagnosed. They will be part of a group that includes their healthcare provider to test a new virtual reality education tool.

Inclusion Criteria

I have recently been diagnosed with cancer or a condition causing bone marrow failure.

I am scheduled for chemotherapy and to get a central line.

Exclusion Criteria

I don't have head injuries or seizures triggered by flashing lights.

I am not planning to undergo chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Groups

Participants will participate in a 45 minute to 1-hour long focus group with similar stakeholders to inform the intervention.

1 week

1 visit (virtual)

Beta Testing

Beta testing of VR-based educational intervention, Life at 100.4, to improve understanding of fever with neutropenia.

1-2 weeks

1 visit (in-person or virtual)

Follow-up

Participants are monitored for feedback on feasibility and usability of the VR tool.

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Life at 100.4

Trial Overview The study is testing 'Life at 100.4,' an immersive social VR tool designed to educate adolescent and young adult cancer patients along with their caregivers. The goal is to assess its feasibility and acceptability through beta testing with patient-caregiver-provider triads.

How Is the Trial Designed?

Group I: Objective 3: Experimental Treatment 1 Intervention

Beta testing of VR-based educational intervention, Life at 100.4, to improve understanding of fever with neutropenia, how and when to check for it, and what to do when they have a fever.

Group II: Objective 1: Focus groups Active Control 1 Intervention

Participants will participate in a 45 minute to 1-hour long focus group with similar stake holders to inform the intervention. These groups will take place via Zoom teleconferencing software, have 4-6 participants per group and will be run by appropriately trained study staff.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

The Glimpse Group Inc

Collaborator

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07224204

Life at 100.4: An Immersive Social Virtual Reality (VR) ... The purpose of this study is to design and Beta test the Life at 100.4, an immersive social virtual reality education tool, with an anticipated ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pbc.31909

“Techquity” in Pediatric, Adolescent, and Young Adult ... Life at 100.4 is an innovative VR educational tool designed to educate cancer patients and their caregivers about febrile neutropenia. As the ...

3. ctv.veeva.com ctv.veeva.com/study/life-at-1004-an-immersive-social-virtual-reality-vr-education-tool-for-adolescent-and-young-adul

Life at 100.4: An Immersive Social Virtual Reality (VR ... Effective, and evidence-based educational experiences can reduce morbidity and mortality rates related to febrile neutropenia. This proposal ...

4. app.trialscreen.org app.trialscreen.org/trials/life-100-4-immersive-social-virtual-reality-vr-education-tool-adolescent-trial-nct07224204

An Immersive Social Virtual Reality (VR) Education Tool for ... To test whether a virtual reality education program called 'Life at 100.4' can effectively teach young cancer patients and their caregivers ...

5. reporter.nih.gov reporter.nih.gov/project-details/9475093

Improving Child Pedestrian Safety This project will study the efficacy of using virtual reality to train children in safe pedestrian behavior. Results will have significant implications for ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT07224204

Life at 100.4: An Immersive Social Virtual Reality (VR) ... Life at 100.4: An Immersive Social Virtual Reality (VR) Education Tool for Adolescent and Young Adult Cancer Patients and Caregivers ... Download Trial Data.