Feasibility Study of Virtual Reality Software to Reduce Stress in Cancer Patients Receiving Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Proportion of patients who complete 2 VR sessions
研究概览
简要总结
The purpose of this study is to test the ability of virtual reality-based social support to increase patient adherence to radiation therapy by reducing patient distress.
详细描述
This study will involve patients who have been diagnosed with breast or head and neck cancer and are suitable to receive radiation therapy. It is a single arm pilot trial designed to provide information on the safety, feasibility, and impacts of incorporating virtual reality (VR) software into the treatment plan of patients receiving radiation therapy with the goal of increasing patient adherence to radiation therapy.
Patients will be provided with VR-based education sessions prior to and during the course of radiation therapy. Patients' emotional and social distress levels will be assessed with questionnaires to measure the impacts of the VR software. Patients will be in the study for up to 3 months during regular cancer care, but the total time for the study procedures is anticipated to be 2-4 hours in total. Results from this study will be for research only and will not impact treatment decisions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Age ≥ 18 years old
- •Must be able to read and speak English
- •Diagnosis of breast or head and neck cancer
- •Treatment plan includes radiotherapy within the next 2 months
- •Signed study-specific informed consent prior to study entry
排除标准
- •Previous radiation therapy treatment
- •Neurologic deficits
- •Visual disorder
- •Neuro-psychiatric disorder
- •Use of neuro-psychiatric drugs
结局指标
主要结局
Proportion of patients who complete 2 VR sessions
时间窗: Up to 3 Months
Percentage of patients who complete 2 VR sessions will be calculated.
Proportion of patients reporting ease of use for VR sessions
时间窗: Up to 3 Months
Patients will be given a survey on their VR sessions to measure the ease of use and ability to provide useful information.
Proportion of overall adherence to radiation therapy
时间窗: Up to 3 Months
Patient adherence to radiation treatment will be recorded and proportion of overall adherence will be calculated.
次要结局
- Change in brief symptom inventory(Up to 3 Months)
- Change in state trait anxiety scale(Up to 3 Months)
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Item Bank v2.0 - Social Isolation - Short Form 8a (SI)(Up to 3 Months)