Pilot Study to Assess Safety, Tolerability and Efficacy of Virtual Reality in Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Successfully complete the virtual reality (VR) intervention (Feasibility)
研究概览
简要总结
This clinical trial tests the safety, tolerability, and effectiveness of a virtual reality intervention to improve psychological symptom burden for cancer patients undergoing treatment. Virtual reality (VR) is a technology that allows users to experience and interact with three-dimensional, computer-generated environments that simulate the real world or imagined settings. The VR intervention consists of a preloaded with immersive environments designed to engage the senses through simulated sights and sounds. This may include a walk through of a serene forest, exploring vibrant coral reefs, swimming with dolphins, or standing at the base of a majestic waterfall. These environments are created to provide a relaxing and engaging experience. Completing the VR intervention may be a safe and effective way to improve quality of life, reduce anxiety, enhance focus, and promote healthy living for cancer patients undergoing treatment.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of cancer
- •Age between 18 to 90 years
- •Undergoing in-patient chemotherapy, bone marrow transplant (BMT), chimeric antigen receptor (CAR)-t, & out-patient chemotherapy
排除标准
- •History of bipolar disorder, major depression, bipolar disorder, anxiety disorder, post traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), psychotic disorder, schizophrenia, personality disorder, substance use disorder other than caffeine or tobacco. History of suicidal ideation or attempt
- •History of treatment resistant depression, psychiatric hospitalization, syncope, transient ischemic attack (TIA), stroke, epilepsy, electroconvulsive therapy, benign positional vertigo, Meniere's disease
研究组 & 干预措施
Virtual Reality (VR) Headset Intervention
Participants will undergo a single VR session to assess feasibility, tolerability, and changes in anxiety, depression, and fatigue.
干预措施: Questionnaire Administration (Other)
Virtual Reality (VR) Headset Intervention
Participants will undergo a single VR session to assess feasibility, tolerability, and changes in anxiety, depression, and fatigue.
干预措施: Virtual Reality (VR) Intervention (Other)
结局指标
主要结局
Successfully complete the virtual reality (VR) intervention (Feasibility)
时间窗: Baseline
Feasibility of VR will be assessed by the proportion of participants who successfully complete the intervention.
Absence of major issues during administration (Feasibility)
时间窗: Baseline
Feasibility of VR will be evaluated by the absence of (low/no recorded incidence of) major technical or usability issues during administration
Acceptability
时间窗: Baseline
Will be assessed via the Post-Study Exit Interview Questionnaire, a questionnaire developed specifically for this study. It consists of 17 questions. Eight questions relate to the VR experience (e.g., comfort of headset, control of actions in VR environment, understandability of instructions, technical issues). Five questions relate to symptoms (e.g., dizziness, nausea, headache) or discomfort experienced during and immediately following VR use. The remaining questions relate to helpfulness of intervention, improvement suggestions, other feedback, and interest in learning more about services and resources. Results will be analyzed descriptively.
Successfully complete the virtual reality (VR) intervention (Feasibility)
时间窗: Baseline
Feasibility of VR will be assessed by the proportion of participants who successfully complete the intervention.
Absence of major issues during administration (Feasibility)
时间窗: Baseline
Feasibility of VR will be evaluated by the absence of (low/no recorded incidence of) major technical or usability issues during administration
Acceptability
时间窗: Baseline
Will be assessed via the Post-Study Exit Interview Questionnaire, a questionnaire developed specifically for this study. It consists of 17 questions. Eight questions relate to the VR experience (e.g., comfort of headset, control of actions in VR environment, understandability of instructions, technical issues). Five questions relate to symptoms (e.g., dizziness, nausea, headache) or discomfort experienced during and immediately following VR use. The remaining questions relate to helpfulness of intervention, improvement suggestions, other feedback, and interest in learning more about services and resources. Results will be analyzed descriptively.
次要结局
- Change in anxiety(Baseline (pre- to post-intervention, approximately 1.5 hours))
- Change in depression(Baseline (pre- to post-intervention, approximately 1.5 hours))
- Change in fatigue(Baseline (pre- to post-intervention, approximately 1.5 hours))
- Change in overall quality of life(Baseline (pre- to post-intervention, approximately 1.5 hours))