Virtual Reality in Lung Cancer Patients

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.

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