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

February 24, 2026 updated by: Yale University

Life at 100.4: An Immersive Social Virtual Reality Education Tool for Adolescent and Young Adult Cancer Patients and Caregivers

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 5 patient-caregiver-provider triads.Patients at Yale Pediatric Hematology and Oncology with a new oncologic diagnosis and their caregivers will be eligible for enrollment. Investigators will determine the feasibility and acceptability of implementing Life at 100.4 using validated measures.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • Pediatric Hematology/Oncology Clinic in Smilow Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
Behavioral: Life at 100.4
An Immersive Social Virtual Reality Education Tool, participation up to 2 hours

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Nursing Research (NINR)
The Glimpse Group Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Asher Marks, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 11, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2000040734
  • 1R41NR022239 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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