Lung Neoplasms (D008175)ViRePICINCT07755501
Virtual Reality in Lung Cancer Patients
A study testing Immersive Virtual Reality in people with Lung Neoplasms (D008175), run by Dott.Claudio Sini at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 80 years
- Conditions the study is for
- Lung Neoplasms (D008175)
- What is being tested?
- Immersive Virtual Reality
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2027to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Use of antipsychotic medications
- Epilepsy
- Use of illicit drugs or alcohol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Giovanni Paolo II Hospital, Medical Oncology Unit, ASL Gallura
Olbia, Sardinia, 07026
Claudio Sini, MD, +39 320 716 9152, claudio.sini@aslgallura.it
About this study
Official title: Effects of Virtual Reality in Lung Cancer Patients Undergoing Immunotherapy and Chemo-immunotherapy
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Lung Neoplasms (D008175)
- Being tested
- Immersive Virtual Reality
- Keywords
- Virtual Realy, Lung Neoplasms, chemotherapy, Immunotherapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual RealityDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean State-Trait Anxiety Inventory-State (STAI-Y1)
State anxiety will be assessed using the State-Trait Anxiety Inventory Form Y-1 (STAI-Y1), a 20-item self-administered questionnaire measuring anxiety experienced at the time of assessment. Each item is scored on a 4-point Likert scale from 1 to 4. The total score ranges from a minimum of 20 to a maximum of 80. Higher scores indicate greater state anxiety and therefore a worse outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score.
Measured: Baseline and week 9
Secondary outcomes (7)
Percentage of Participants With an Objective Tumor Response
Objective tumor response is defined as a complete response or partial response according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). The percentage of participants meeting either response category by Week 9 will be summarized for each study arm.
Measured: Baseline and Week 9
Geometric Mean Neutrophil-to-Lymphocyte Ratio
The neutrophil-to-lymphocyte ratio will be assessed from blood count data at baseline and Week 9. Week 9 values will be analyzed after logarithmic transformation and summarized using geometric means.
Measured: baseline and week 9
Mean Revised Piper Fatigue Scale Score
Fatigue will be assessed using the Revised Piper Fatigue Scale, a 22-item self-administered questionnaire assessing behavioral severity, affective meaning, sensory severity, and cognitive/mood dimensions of fatigue. Each item is scored from 0 to 10. The overall score is calculated as the mean of the item scores and ranges from a minimum of 0 to a maximum of 10. Higher scores indicate greater fatigue severity and therefore a worse outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score.
Measured: baseline and week 9
Mean Pain Intensity Score on the Visual Analog Scale
Pain intensity will be assessed using the Visual Analog Scale for Pain (VAS-Pain). The score ranges from a minimum of 0 to a maximum of 10, where 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate greater pain intensity and therefore a worse outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score.
Measured: baseline and Week 9
Mean EORTC QLQ-C30 Global Health Status/Quality of Life Score
Quality of life will be assessed using the Global Health Status/Quality of Life scale of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The Global Health Status/Quality of Life score is linearly transformed to a scale ranging from a minimum of 0 to a maximum of 100. Higher scores indicate better perceived global health status and quality of life and therefore a better outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score.
Measured: Baseline and Week 9
Percentage of Participants With Dyspnea
Dyspnea will be recorded as present or absent. The outcome is the percentage of participants with dyspnea at Week 9. Dyspnea status will also be recorded at baseline.
Measured: Baseline and Week 9
Percentage of Participants With Cough
Cough will be recorded as present or absent. The outcome is the percentage of participants with cough at Week 9. Cough status will also be recorded at baseline.
Measured: Baseline and Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start1 Mar 2027 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung Neoplasms (D008175)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dott.Claudio Sini
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Dott.Claudio Sini, Azienda Socio-Sanitaria Locale n. 2 della Gallura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755501
- Sponsor's protocol ID
- VR-LUNG-07
- Acronym
- ViRePICI
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to Share IPD: Undecided IPD Sharing Plan Description: The study will contribute descriptive metadata to the Regional Registry for Biomedical Research (R3B) in accordance with FAIR principles. However, a final decision has not yet been made regarding the sharing of de-identified individual participant data and related data dictionaries with other researchers. Any future data sharing will be subject to applicable data protection legislation, ethics requirements, participant consent, and approval by the study sponsor and ASL Gallura.
Publications
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.
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.
PubMed 15817019Eisenhauer 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.
PubMed 19097774Kim 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.
PubMed 29477332Bachelard 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.
PubMed 39682131Burrai 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.
PubMed 37290160Burrai 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.
PubMed 37455151
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality in Lung Cancer Patients Undergoing Immunotherapy and Chemo-immunotherapy
- ClinicalTrials.gov ID
- NCT07755501
- Acronym / sponsor ID
- ViRePICI / VR-LUNG-07
- Conditions
- Lung Neoplasms (D008175)
- Keywords
- Virtual Realy, Lung Neoplasms, chemotherapy, Immunotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dott.Claudio SiniOther government
- Study start
- 1 Mar 2027 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Plus Standard Care | Experimental | Device: Immersive Virtual RealityParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 months to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Use of antipsychotic medications
- Epilepsy
- Use of illicit drugs or alcohol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual RealityParticipants 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. | Device | Virtual Reality Plus Standard Care |
Primary outcome
Mean State-Trait Anxiety Inventory-State (STAI-Y1)
Time frame: Baseline and week 9
State anxiety will be assessed using the State-Trait Anxiety Inventory Form Y-1 (STAI-Y1), a 20-item self-administered questionnaire measuring anxiety experienced at the time of assessment. Each item is scored on a 4-point Likert scale from 1 to 4. The total score ranges from a minimum of 20 to a maximum of 80. Higher scores indicate greater state anxiety and therefore a worse outcome. The Week 9 score will be compared between study arms with adjustment for the corresponding baseline score.
7 secondary outcomes
Percentage of Participants With an Objective Tumor Response
Time frame: Baseline and Week 9
Geometric Mean Neutrophil-to-Lymphocyte Ratio
Time frame: baseline and week 9
Mean Revised Piper Fatigue Scale Score
Time frame: baseline and week 9
Mean Pain Intensity Score on the Visual Analog Scale
Time frame: baseline and Week 9
Mean EORTC QLQ-C30 Global Health Status/Quality of Life Score
Time frame: Baseline and Week 9
Percentage of Participants With Dyspnea
Time frame: Baseline and Week 9
Percentage of Participants With Cough
Time frame: Baseline and Week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
- Background: PubMed 15817019Nasreddine 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.
- Background: PubMed 19097774Eisenhauer 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.
- Background: PubMed 29477332Kim 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.
- Background: PubMed 39682131Bachelard 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.
- Background: PubMed 37290160Burrai 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.
- Background: PubMed 37455151Burrai 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.
- Individual participant dataSharing planned: Undecided. Plan to Share IPD: Undecided IPD Sharing Plan Description: The study will contribute descriptive metadata to the Regional Registry for Biomedical Research (R3B) in accordance with FAIR principles. However, a final decision has not yet been made regarding the sharing of de-identified individual participant data and related data dictionaries with other researchers. Any future data sharing will be subject to applicable data protection legislation, ethics requirements, participant consent, and approval by the study sponsor and ASL Gallura.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immersive Virtual Reality in people with Lung Neoplasms (D008175), run by Dott.Claudio Sini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudio Sini, MD (+39 320 716 9152, claudio.sini@aslgallura.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean State-Trait Anxiety Inventory-State (STAI-Y1) (time frame: Baseline and week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07755501, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.