Virtual Reality to Promote Mindfulness and Relaxation Prior to Radiation Simulation: a Prospective Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Feasibility of a pre-simulation VR platform prior to radiation
研究概览
简要总结
The purpose of this study is to assess the feasibility of a pre-simulation virtual reality (VR) platform designed to promote relaxation for cancer patients planned for radiation therapy (RT).
详细描述
The purpose of this prospective feasibility study is to assess the implementation of a VR-based intervention in patients who are pending initiation of RT. The investigators hypothesize that this intervention will be safe and feasible. If 75% of enrolled patients complete the VR intervention (defined as at least 8 min before permanent discontinuation), then feasibility will be met. Ten minutes' length is likely to be tolerated by most patients and likely to provide benefit. The maximum length of the VR video is 11 minutes. Patients will still be evaluable after 8 minutes of the video as this provides ample time to practice mindfulness based breathing exercises.
As this is a feasibility study, investigators and participants will not be blinded to study procedures. Potential study participants will be adult patients who are undergoing simulation for radiation treatment planning at the Perelman Center for Advanced Medicine at Penn Medicine. This is a single site study. No interim analyses or sub-studies are planned. Based on the expected accrual of 25 patients, futility and early termination will be triggered if 6 participants fail to meet the conditions described above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand, read or speak English sufficient for signing of informed consent and completion of study assessments
- •Patients scheduled for simulation for radiation treatment planning at Perelman Center for Advanced Medicine (PCAM)
- •Adults, at least 18 years of age
- •Performance Status (ECOG) 0-2
排除标准
- •Prior radiotherapy
- •History of motion sickness, car sickness, vertigo, migraines, or light sensitivity within the last 6 months
- •History of epilepsy and seizures
- •Current nausea, vomiting, dizziness, lightheadedness, monocular vision or hearing loss that is not treated
结局指标
主要结局
Feasibility of a pre-simulation VR platform prior to radiation
时间窗: 12 months
Feasibility based on the ability of at least 75% patient VR completion rate. Based on the expected accrual of 25 patients, futility and early termination will be triggered if six participants fail to meet the conditions described above.
次要结局
- Patient situational anxiety prior to and after use of VR program (STAI-6)(12 months)
- Patient feedback on pre-simulation VR program(12 months)
- Patient situational anxiety prior to and after use of VR program (HADS)(12 months)
研究者
Michael LaRiviere, MD
Assistant Professor of Radiation Oncology
Abramson Cancer Center at Penn Medicine