跳至主要内容
临床试验/NCT07224204
NCT07224204招募中不适用

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

Yale University1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
1
主要终点
Technology Acceptance Model (TAC)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
13 Years 至 39 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: Life at 100.4 (Behavioral)

结局指标

主要结局

Technology Acceptance Model (TAC)

时间窗: 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.

Multimodal Presence Scale for Virtual Environments

时间窗: 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.

System Usability Scale (SUS)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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