Virtual Reality in Lung Cancer Patients

NCT07755501 | Not Yet Recruiting

• 1 other identifier: VR-LUNG-07
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms (D008175)

Keywords

Virtual Realy; Lung Neoplasms; chemotherapy; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Mean State-Trait Anxiety Inventory-State (STAI-Y1) Score at Week 9

  The STAI-Y1 is a 20-item self-administered questionnaire that measures current state anxiety. Each item is rated on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating greater state anxiety. The Week 9 score will be compared between study arms, with the baseline STAI-Y1 score and type of anticancer treatment (immunotherapy versus chemo-immunotherapy) included as covariates.

  Week 9

Secondary Outcomes (7)

• Percentage of Participants With an Objective Tumor Response by Week 9

  From baseline through Week 9

• Geometric Mean Neutrophil-to-Lymphocyte Ratio at Week 9

  Week 9

• Mean Revised Piper Fatigue Scale Score at Week 9

  Week 9

• Mean Pain Intensity Score on the Visual Analog Scale at Week 9

  Week 9

• Mean EORTC QLQ-C30 Global Health Status/Quality of Life Score at Week 9

  Week 9

Other Outcomes (4)

• Virtual Reality Symptom Questionnaire Score After Each Virtual Reality Session

  Immediately after each virtual reality session at Weeks 3, 6, and 9

• Virtual Reality Patient Satisfaction Questionnaire Score at Week 9

  Week 9

• Number of Participants Who Withdraw From the Study

  From enrollment through Week 9

Study Arms (2)

Virtual Reality Plus Standard Care

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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.

Interventions

Immersive Virtual Reality DEVICE

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.

Virtual Reality Plus Standard Care

Eligibility Criteria

• Age: 18 Months - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of antipsychotic medications
• Epilepsy
• Use of illicit drugs or alcohol

Sponsors & Collaborators

• Dott.Claudio Sini: lead

Study Sites (1)

Giovanni Paolo II Hospital, Medical Oncology Unit, ASL Gallura

Olbia, Sardinia, 07026, Italy

Location

Related Publications (7)

• 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.

  BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 19097774 BACKGROUND

• 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.

  PMID: 29477332 BACKGROUND

• 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.

  PMID: 39682131 BACKGROUND

• 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.

  PMID: 37290160 BACKGROUND

• 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.

  PMID: 37455151 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Claudio Sini, MD

CONTACT

+39 320 716 9152; claudio.sini@aslgallura.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Oncologist

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

IT (1)