- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07224204
Life at 100.4: An Immersive Social Virtual Reality (VR) Education Tool for Adolescent and Young Adult Cancer Patients and Caregivers
Life at 100.4: An Immersive Social Virtual Reality Education Tool for Adolescent and Young Adult Cancer Patients and Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Febrile neutropenia, a condition marked by fever and low numbers of neutrophils, is the most commonly encountered complication of childhood cancer treatment. The mortality of untreated febrile neutropenia is as high as 30%. Delay of appropriate care and increased time to antibiotics are associated with increased mortality. Reasons for delay to care include a lack of understanding about the seriousness of febrile neutropenia or difficulty navigating the healthcare system. Effective, and evidence-based educational experiences can reduce morbidity and mortality rates related to febrile neutropenia. This proposal aims to combat knowledge gaps surrounding febrile neutropenia through the creation of an immersive social VR-based intervention, Life at 100.4. This program will provide critical education to patients and caregivers related to febrile neutropenia during cancer treatment. This work will result in the development of a critical new tool specific to febrile neutropenia while establishing VR more broadly as an effective patient and caregiver education tool, particularly for the near 40% of the population with low health literacy.
Objective 1 will include a qualitative study comprising interviews and focus groups with key stakeholders conducted by the Yale team to understand attitudes, perceptions, and knowledge around the navigation of febrile neutropenia.
Objective 2 will be the production of a VR-based prototype.
Objective 3, the focus of this registration, will assess feasibility and usability of this education tool.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Asher Marks, MD
- Phone Number: 203-785-4640
- Email: asher.marks@yale.edu
Study Contact Backup
- Name: Vidya Puthepura, MD
- Phone Number: 203-785-4640
- Email: vidya.puthenpura@yale.edu
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06520
- Recruiting
- Pediatric Hematology/Oncology Clinic in Smilow Cancer Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Newly diagnosed with a malignancy or bone marrow failure condition
- Planned to receive chemotherapy and receive a central line
Exclusion Criteria:
- Medical contraindication to virtual reality including head wounds and history of seizure with flashing lights
- No plan to receive chemotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Objective 1: Focus groups
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.
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|
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Experimental: Objective 3:
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.
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An Immersive Social Virtual Reality Education Tool, participation up to 2 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Multimodal Presence Scale for Virtual Environments
Time Frame: immediately post-intervention, up to 2 hours
|
A 15-item validated tool to assess presence in VR.
There are five items for each of the three dimensions, Physical Presence, Social Presence, and Self-Presence, scored on a 5-point Likert scale, from 1 (strongly disagree) to 5 (strongly agree).
Total score for each dimension 1-5 with higher scores indicating a stronger sense of presence in that dimension.
|
immediately post-intervention, up to 2 hours
|
|
System Usability Scale (SUS)
Time Frame: immediately post-intervention, up to 2 hours
|
A 10-item questionnaire with responses provided on a Likert scale.
The SUS has been applied in evaluating the usability of different websites, software, and human computer interfaces.
The final score is on a scale of 0-100.
Higher scores indicate more usability.
|
immediately post-intervention, up to 2 hours
|
|
Technology Acceptance Model (TAC)
Time Frame: immediately post-intervention, up to 2 hours
|
Technology Acceptance Model questionnaire with questions related to Perceived Usefulness and Perceived Ease of Use.
Total score range 1-5 with higher scores indicating higher acceptance and use.
|
immediately post-intervention, up to 2 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Asher Marks, MD, Yale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000040734
- 1R41NR022239 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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