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

NCT ID: NCT07224204

Last Updated: 2025-11-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-04-30

Brief Summary

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.

Conditions

Cancer; Adolescent Cancer; Young Adult Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Life at 100.4

Intervention Type: BEHAVIORAL

An Immersive Social Virtual Reality Education Tool, participation up to 2 hours

Interventions

Life at 100.4

An Immersive Social Virtual Reality Education Tool, participation up to 2 hours

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Glimpse Group Inc

UNKNOWN

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asher Marks, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Pediatric Hematology/Oncology Clinic in Smilow Cancer Hospital

New Haven, Connecticut, United States

Countries

United States

Central Contacts

Asher Marks, MD

Role: CONTACT

asher.marks@yale.edu

203-785-4640

Vidya Puthepura, MD

Role: CONTACT

vidya.puthenpura@yale.edu

203-785-4640

Other Identifiers

1R41NR022239

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000040734

Identifier Type: -

Identifier Source: org_study_id