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NOT YET RECRUITING
NCT07755501
NA

Virtual Reality in Lung Cancer Patients

Sponsor: Dott.Claudio Sini

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Months - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2027-03-01

Completion Date

2027-12-31

Last Updated

2026-08-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

Giovanni Paolo II Hospital, Medical Oncology Unit, ASL Gallura

Olbia, Sardinia, Italy