NCT07224204

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
11mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Feb 2026Apr 2027

First Submitted

Initial submission to the registry

October 31, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

February 11, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.1 years

First QC Date

October 31, 2025

Last Update Submit

February 24, 2026

Conditions

Keywords

Adolescent Cancer Patients and CaregiversYoung Adult Cancer Patients and Caregivers

Outcome Measures

Primary Outcomes (3)

  • Multimodal Presence Scale for Virtual Environments

    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)

    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)

    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

Study Arms (2)

Objective 1: Focus groups

NO 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.

Objective 3:

EXPERIMENTAL

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

Interventions

Life at 100.4BEHAVIORAL

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

Objective 3:

Eligibility Criteria

Age13 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Newly diagnosed with a malignancy or bone marrow failure condition
  • Planned to receive chemotherapy and receive a central line

You may not qualify if:

  • Medical contraindication to virtual reality including head wounds and history of seizure with flashing lights
  • No plan to receive chemotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Hematology/Oncology Clinic in Smilow Cancer Hospital

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Asher Marks, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asher Marks, MD

CONTACT

Vidya Puthepura, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: For Objective 1, an anticipated 20-30 participants for focus groups. For Objective 3, an anticipated 15 participant-caregiver-provider triads. Participants with new oncologic diagnosis and their caregivers at the Yale Pediatric Hematology/Oncology Clinic will be eligible for enrollment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2025

First Posted

November 4, 2025

Study Start

February 11, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations