Clinical trial · Interventional
Virtual Reality in Lung Cancer Patients
Effects of Virtual Reality in Lung Cancer Patients Undergoing Immunotherapy and Chemo-immunotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Neoplasms (D008175) | Lung Neoplasm | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Immersive Virtual Reality | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Virtual Reality Plus Standard Care
- description
- 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.
- interventionNames
- Device: Immersive Virtual Reality
- type
- NO_INTERVENTION
- label
- Standard Care
- description
- 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.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Months
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDSnoswell 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.
- BACKGROUNDNasreddine 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
- BACKGROUNDEisenhauer 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
- BACKGROUNDKim 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
- BACKGROUNDBachelard 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
- BACKGROUNDBurrai 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
- BACKGROUNDBurrai 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.