Lung Neoplasms (D008175)
Conditions
Keywords
Virtual Realy, Lung Neoplasms, chemotherapy, Immunotherapy
Brief summary
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.
Detailed description
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. Participants will be free to select the virtual content they prefer, adjust the audio volume, and move their eyes and head normally. They may remove the headset at any time and may subsequently resume the VR experience. The VR session may continue for the duration of the infusion. VR sessions will be conducted at baseline, week 3, week 6, and week 9. Participants assigned to the Standard Care Group will receive the usual clinical and nursing care provided during 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, but they will not use a VR headset or immersive content provided by the study. The primary outcome is state anxiety, assessed using the State-Trait Anxiety Inventory-State subscale (STAI-Y1) at baseline and at week 9. The primary hypothesis is that participants assigned to VR will have a lower mean STAI-Y1 score at week 9 than participants assigned to standard care. Secondary exploratory outcomes include objective response rate, neutrophil-to-lymphocyte ratio, fatigue, pain, quality of life, dyspnea, and cough. Cybersickness will be assessed following the VR sessions, and satisfaction with VR will be evaluated at week 9. Adverse reactions, participant withdrawals, and reasons for withdrawal will also be recorded.
Interventions
DEVICEImmersive Virtual Reality
Participants assigned to the experimental arm will receive immersive virtual reality using a standalone Meta Quest 3S 128 GB head-mounted display. The headset will contain offline 360-degree audiovisual content in 4K to 8K resolution with high-definition stereo audio. The available content will primarily depict natural environments, including hills, rivers, lakes, waterfalls, islands, deserts, beaches, mountains, marine environments, and underwater environments. A healthcare professional trained in the study protocol will help the participant put on the headset approximately 15 minutes before the start of the scheduled immunotherapy or chemo-immunotherapy infusion. The virtual reality session will continue for the duration of the infusion. Participants may select their preferred content, adjust the audio volume, move their eyes and head freely, and remove or replace the headset at any time. Three sessions will be administered at weeks 3, 6, and 9 after baseline.
Sponsors
Dott.Claudio Sini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
This is a single-center, prospective, randomized, controlled, two-arm parallel-group superiority trial. Participants will be randomized in a 1:1 ratio to immersive virtual reality plus standard care or standard care alone and will remain in their assigned group throughout the 9-week study period. Outcome assessments will be performed at baseline and at week 9. Participants assigned to the virtual reality group will receive three immersive virtual reality sessions during scheduled infusions at weeks 3, 6, and 9.
Eligibility
Sex/Gender
ALL
Age
18 Months to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Use of antipsychotic medications * Epilepsy * Use of illicit drugs or alcohol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean State-Trait Anxiety Inventory-State (STAI-Y1) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Objective Tumor Response | Baseline and Week 9 | Objective tumor response is defined as a complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The percentage of participants meeting either response category by Week 9 will be summarized for each study arm. |
| Geometric Mean Neutrophil-to-Lymphocyte Ratio | baseline and week 9 | The neutrophil-to-lymphocyte ratio will be assessed from blood count data at baseline and Week 9. Week 9 values will be analyzed after logarithmic transformation and summarized using geometric means. |
| Mean Revised Piper Fatigue Scale Score | baseline and week 9 | Fatigue will be assessed using the Revised Piper Fatigue Scale, a 22-item self-administered questionnaire assessing behavioral severity, affective meaning, sensory severity, and cognitive/mood dimensions of fatigue. Each item is scored from 0 to 10. The overall score is calculated as the mean of the item scores and ranges from a minimum of 0 to a maximum of 10. Higher scores indicate greater fatigue severity and therefore a worse outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score. |
| Mean Pain Intensity Score on the Visual Analog Scale | baseline and Week 9 | Pain intensity will be assessed using the Visual Analog Scale for Pain (VAS-Pain). The score ranges from a minimum of 0 to a maximum of 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity and therefore a worse outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score. |
| Mean EORTC QLQ-C30 Global Health Status/Quality of Life Score | Baseline and Week 9 | Quality of life will be assessed using the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The Global Health Status/Quality of Life score is linearly transformed to a scale ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better perceived global health status and quality of life and therefore a better outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score. |
| Percentage of Participants With Dyspnea | Baseline and Week 9 | Dyspnea will be recorded as present or absent. The outcome is the percentage of participants with dyspnea at Week 9. Dyspnea status will also be recorded at baseline. |
| Percentage of Participants With Cough | Baseline and Week 9 | Cough will be recorded as present or absent. The outcome is the percentage of participants with cough at Week 9. Cough status will also be recorded at baseline. |
Countries
Italy
Contacts
CONTACTClaudio Sini, MD
Outcome results
None listed