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Recruiting NCT07224204

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

No phase Interventional Cancer Adolescent Cancer Young Adult Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Life at 100.4.
Who it may be relevant to
Registry conditions: Cancer, Adolescent Cancer, Young Adult Cancer. Basic parameters: 13 years — 39 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • Behavioral Life at 100.4
    An Immersive Social Virtual Reality Education Tool, participation up to 2 hours

Primary outcome measures

  • Multimodal Presence Scale for Virtual Environments [Time frame: immediately post-intervention, up to 2 hours]
  • System Usability Scale (SUS) [Time frame: immediately post-intervention, up to 2 hours]
  • Technology Acceptance Model (TAC) [Time frame: immediately post-intervention, up to 2 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Pediatric Hematology/Oncology Clinic in Smilow Cancer Hospital — New Haven

Identifiers

NCT: NCT07224204 · 2000040734 · 1R41NR022239

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗