Virtual Reality in Lung Cancer Patients (ViRePICI)

Effects of Virtual Reality in Lung Cancer Patients Undergoing Immunotherapy and Chemo-immunotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Neoplasms (D008175)
• Intervention / Treatment: Device: Immersive Virtual Reality

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claudio Sini, MD; Phone Number: +39 320 716 9152; Email: claudio.sini@aslgallura.it

Study Locations

• Italy
  • Sardinia
    • Olbia, Sardinia, Italy, 07026
      • Giovanni Paolo II Hospital, Medical Oncology Unit, ASL Gallura
      • Contact: Claudio Sini, MD; Phone Number: +39 320 716 9152; Email: claudio.sini@aslgallura.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Immersive 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean State-Trait Anxiety Inventory-State (STAI-Y1)	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.	Baseline and week 9

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Objective Tumor Response	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.	Baseline and Week 9
Geometric Mean Neutrophil-to-Lymphocyte Ratio	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.	baseline and week 9
Mean Revised Piper Fatigue Scale Score	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.	baseline and week 9
Mean Pain Intensity Score on the Visual Analog Scale	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.	baseline and Week 9
Mean EORTC QLQ-C30 Global Health Status/Quality of Life Score	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.	Baseline and Week 9
Percentage of Participants With Dyspnea	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.	Baseline and Week 9
Percentage of Participants With Cough	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.	Baseline and Week 9

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Withdraw From the Study	The number of participants who withdraw from the study and the reported reasons for withdrawal will be summarized for each study arm.	From enrollment through Week 9
Number of Participants With Adverse Reactions	The number of participants experiencing adverse reactions will be summarized for each study arm. The frequency and clinical description of the reported adverse reactions will be recorded.	From enrollment through Week 9
Virtual Reality Symptom Questionnaire Score	Cybersickness symptoms will be assessed in participants assigned to the experimental arm using the Virtual Reality Symptom Questionnaire. The questionnaire contains 23 symptoms, including 12 non-ocular and 11 ocular symptoms. Each symptom is scored on a 7-point scale from 0 to 6. The total score is calculated by summing the 23 item scores and ranges from a minimum of 0 to a maximum of 138. Higher scores indicate greater severity of cybersickness symptoms and therefore a worse outcome. The questionnaire will be completed immediately after each virtual reality session.	Weeks 3, 6, and 9
Virtual Reality Patient Satisfaction Questionnaire Score	Participant satisfaction with the virtual reality intervention will be assessed in participants assigned to the experimental arm using the Virtual Reality Patient Satisfaction Questionnaire, an 8-item ad hoc questionnaire. Each item is scored on a 5-point Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is calculated by summing the 8 item scores and ranges from a minimum of 8 to a maximum of 40. Higher scores indicate greater satisfaction with the virtual reality intervention and therefore a better outcome.	Week 9

Collaborators and Investigators

• Sponsor: Dott.Claudio Sini

Publications and helpful links

General Publications

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.
• Kim HK, Park J, Choi Y, Choe M. Virtual reality sickness questionnaire (VRSQ): Motion sickness measurement index in a virtual reality environment. Appl Ergon. 2018 May;69:66-73. doi: 10.1016/j.apergo.2017.12.016. Epub 2018 Jan 16.
• Burrai F, Ortu S, Marinucci M, De Marinis MG, Piredda M. Effectiveness of Immersive Virtual Reality in People with Cancer Undergoing Antiblastic Therapy: A Randomized Controlled Trial. Semin Oncol Nurs. 2023 Aug;39(4):151470. doi: 10.1016/j.soncn.2023.151470. Epub 2023 Jul 16.
• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
• Snoswell AJ, Snoswell CL. Immersive Virtual Reality in Health Care: Systematic Review of Technology and Disease States. JMIR Biomed Eng. 2019;4(1):e15025. doi:10.2196/15025.
• Bachelard L, Michel A, Blanc N. Virtual Reality to Improve the Psychological and Physical Well-Being in Cancer Patients: An Umbrella Review. Cancers (Basel). 2024 Nov 25;16(23):3943. doi: 10.3390/cancers16233943.
• Burrai F, Sguanci M, Petrucci G, De Marinis MG, Piredda M. Effectiveness of immersive virtual reality on anxiety, fatigue and pain in patients with cancer undergoing chemotherapy: A systematic review and meta-analysis. Eur J Oncol Nurs. 2023 Jun;64:102340. doi: 10.1016/j.ejon.2023.102340. Epub 2023 May 16.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 5, 2026
• First Submitted That Met QC Criteria: August 5, 2026
• First Posted (Actual): August 10, 2026

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: chemotherapy; Immunotherapy; Lung Neoplasms; Virtual Realy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: VR-LUNG-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

Plan to Share IPD: Undecided

IPD Sharing Plan Description:

The study will contribute descriptive metadata to the Regional Registry for Biomedical Research (R3B) in accordance with FAIR principles. However, a final decision has not yet been made regarding the sharing of de-identified individual participant data and related data dictionaries with other researchers. Any future data sharing will be subject to applicable data protection legislation, ethics requirements, participant consent, and approval by the study sponsor and ASL Gallura.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No