Effects of Virtual Reality in Lung Cancer Patients Undergoing Immunotherapy and Chemo-immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean State-Trait Anxiety Inventory-State (STAI-Y1)
研究概览
简要总结
The goal of this randomized clinical trial is to determine whether immersive virtual reality (VR), delivered during scheduled immunotherapy or chemo-immunotherapy infusions, can reduce state anxiety in patients with lung cancer compared with standard care.
The main question this study aims to answer is whether participants assigned to the VR group will have a lower mean State-Trait Anxiety Inventory-State score (STAI-Y1) at week 9 than participants assigned to standard care.
A total of 60 participants will be randomly assigned in a 1:1 ratio to receive either VR plus standard care or standard care alone. Participants assigned to the VR group will use immersive VR during four infusion visits: at baseline, week 3, week 6, and week 9. Each VR session will begin 15 minutes before the start of the infusion and may continue for the duration of the infusion.
The study will also explore the effects of VR on objective tumor response, neutrophil-to-lymphocyte ratio, fatigue, pain, quality of life, dyspnea, and cough. Cybersickness, participant satisfaction, adverse reactions, and study withdrawal will also be assessed.
详细描述
Immersive virtual reality is a non-pharmacological intervention that may support patients during cancer treatment by redirecting attention away from the hospital environment and promoting distraction, presence, immersion, and interaction. Evidence on the effects of immersive VR specifically in patients with lung cancer receiving immunotherapy or chemo-immunotherapy remains limited. This study is designed to evaluate the efficacy and safety of VR in this clinical population.
This is a single-center, prospective, randomized, controlled, two-parallel-group superiority trial. A total of 60 participants will be allocated in a 1:1 ratio to either the Virtual Reality Group or the Standard Care Group. The randomization sequence will be generated using validated software by an independent researcher who is not involved in participant recruitment or outcome assessment.
At baseline, eligibility will be assessed and written informed consent will be obtained before any study-specific procedure. Sociodemographic and clinical information and baseline outcome measurements will then be collected. Participants will be randomized after completion of the baseline assessments and before the start of the scheduled infusion.
Participants assigned to the Virtual Reality Group will receive usual clinical care plus immersive VR. The intervention will be delivered using a standalone Meta Quest 3S 128 GB head-mounted display containing offline 360-degree audiovisual content. The virtual environments will primarily include natural settings, such as hills, rivers, lakes, waterfalls, islands, deserts, beaches, mountains, marine environments, and underwater environments.
Before the first session, a healthcare professional trained in the study protocol will explain how to use the VR equipment and how to select content from the available playlist. During each session, the participant will be seated in an infusion chair or lying on a treatment bed. The trained healthcare professional will place the headset approximately 15 minutes before the start of the infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Months 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 18 years
- •Diagnosis of lung cancer with an indication for intravenous immunotherapy or chemo-immunotherapy
- •Montreal Cognitive Assessment (MoCA) score of 26 or higher
- •No significant hearing impairment
- •No significant visual impairment
- •Sufficient ability to read and write in Italian
排除标准
- •Use of antipsychotic medications
- •Use of illicit drugs or alcohol
研究组 & 干预措施
Virtual Reality Plus Standard Care
Participants will receive standard clinical care during their scheduled immunotherapy or chemo-immunotherapy infusions, together with three immersive virtual reality sessions administered at weeks 3, 6, and 9. Each virtual reality session will begin approximately 15 minutes before the start of the infusion and may continue for the duration of the infusion.
干预措施: Immersive Virtual Reality (Device)
Standard Care
Participants will receive the usual clinical and nursing care provided during scheduled immunotherapy or chemo-immunotherapy infusions. This includes pre-treatment clinical and nursing assessment, administration of the prescribed treatment, monitoring of clinical parameters and infusion-related reactions, and management of symptoms or adverse events according to routine clinical practice. Participants may talk, rest, use their own telephone, or watch television during the infusion. No virtual reality headset or immersive virtual reality content provided by the study will be used.
结局指标
主要结局
Mean State-Trait Anxiety Inventory-State (STAI-Y1)
时间窗: Baseline and week 9
State anxiety will be assessed using the State-Trait Anxiety Inventory Form Y-1 (STAI-Y1), a 20-item self-administered questionnaire measuring anxiety experienced at the time of assessment. Each item is scored on a 4-point Likert scale from 1 to 4. The total score ranges from a minimum of 20 to a maximum of 80. Higher scores indicate greater state anxiety and therefore a worse outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score.
次要结局
- Percentage of Participants With an Objective Tumor Response(Baseline and Week 9)
- Geometric Mean Neutrophil-to-Lymphocyte Ratio(baseline and week 9)
- Percentage of Participants With Cough(Baseline and Week 9)
- Mean Revised Piper Fatigue Scale Score(baseline and week 9)
- Mean Pain Intensity Score on the Visual Analog Scale(baseline and Week 9)
- Mean EORTC QLQ-C30 Global Health Status/Quality of Life Score(Baseline and Week 9)
- Percentage of Participants With Dyspnea(Baseline and Week 9)
研究者
Dott.Claudio Sini
Medical Oncologist
Azienda Socio-Sanitaria Locale n. 2 della Gallura