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Virtual Reality in Lung Cancer Patients

NCT07755501 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-12

No results posted yet for this study

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.

Conditions

  • Lung Neoplasms (D008175)

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.

Sponsors & Collaborators

  • Dott.Claudio Sini

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-03-01
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755501 on ClinicalTrials.gov