Tobacco Use CessationNCT06021652
Feasibility, Adoption and Efficacy of A Virtual Reality Smoking Cessation Program for Patients Undergoing Lung Cancer Screening
A study testing MindCotine Virtual reality in people with Tobacco Use Cessation, run by Cedars-Sinai Medical Center.
Trial summary
Lung cancer is the second most common cancer and the leading cause of cancer related deaths in the United States (US . Tobacco use is the leading cause of lung cancer and tobacco control continues to be the primary method of lung cancer prevention. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- MindCotine Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to read and understand informed consent
- Easy access to personal smartphone o Male or female adults who are at high risk for lung cancer and are enrolled in the Cedars-Sinai lung cancer screening program A: Based on USPSTF guidelines: Age 50-80 with 20 or greater pack-year smoking story who continue to smoke B: Based on National Comprehensive Cancer Network (NCCN) guidelines but do not meet the USPSTF guidelines, age 50-unlimited
Who cannot join
- Persons with photosensitive epilepsy will be excluded; flashing scenes in the virtual reality can trigger seizures.
- Any records flagged "break the glass" or "research opt-out."
- Persons who are unable to use smart phone or have a smartphone that is not compatible with a virtual reality app. The app is currently available in English and Spanish, and those who are not fluent in speaking and reading English or Spanish are excluded from the study.
Trial locations and contacts
No sites are listed yet.
Sara Ghandehari, MD contact
About this study
Official title: Feasibility, Adoption and Efficacy of A Virtual Reality Smoking Cessation Program for Patients Undergoing Lung Cancer Screening: A Pilot Trial
Lung cancer is the second most common cancer and the leading cause of cancer related deaths in the United States (US . Tobacco use is the leading cause of lung cancer and tobacco control continues to be the primary method of lung cancer prevention. Smoking cessation interventions (SCIs) are strongly recommended by screening guidelines and have a class A recommendation by the United States Preventive Services Task Force. Currently, a variety of smoking cessation interventions exist, and evidence suggests that pharmacotherapy, such as nicotine replacement therapy, in combination with behavioral interventions is more effective than either intervention alone. Many individuals, however, prefer not to use or are unable to use pharmacotherapy. A variety of behavioral interventions exist to aid in smoking cession. Recently, virtual reality (VR) has emerged as a possible tool to conduct behavior interventions. Previous research has demonstrated that use of VR can improve patient engagement in a variety of chronic disease interventions. Little is known however about the feasibility and adoption of VR in smoking cessation, especially among individuals at high risk for lung cancers. VR based platforms utilize 'cue exposure therapy'. Given that cravings are often triggered by external factors, or cues, cue exposure therapy exposes individuals to repeated drug-related cues and provides them with tools to eliminate cue-induced cravings. Given the inability for all individuals to use pharmacotherapy there remains a critical need to improve adherence to and efficacy of behavioral interventions for smoking cessation. To address this unmet need, the investigators propose, as pilot study, to enroll patients undergoing routine lung cancer screening and who are not interested in or cannot take pharmacologic therapies for smoking cession, to participate in VR based smoking cessation therapy.
Read the detailed description
The purpose of this study is to assess the adoption rate of VR smoking cessation intervention (MindCotine app) in those who are at risk for lung cancer and are participating in a lung cancer screening program.
The investigators will enroll 20 individuals. 10 of whom elect to participate in the VR program and 10 of whom are using standard of care smoking cessation methods.
The study duration is 90 days after completion of the MindCotine VR program. The MindCotine program consists of a 8-week training stage, and includes audiovisual content, cognitive behavioral therapy based self-reflective questions, setting a quit date, and notifications. The audio-visual content includes formal mindfulness exercises involving breathing techniques, body awareness, thought recognition, emotions, and smoking impulses. VR therapy exercises include the following topics: The Act of Smoking; RAIN meditation; Stress at work; Bodily sensations; Deep emotions; Nicotine anonymous; Alcohol as a trigger. Each content consists of a 2 minute animated environment to induce meditative states of mind, 6 minutes of exposure with real people, and 2 more minutes of an animated environment to induce a meditative mindset.
Participants will be surveyed at baseline, 1 day after the completion of the 8 week VR program and again 90 days after the completion of the VR program.
- Conditions
- Tobacco Use Cessation
- Being tested
- MindCotine Virtual reality
- Keywords
- Tobacco use, Virtual Reality, Smoking cessation
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindCotine Virtual realityDevice
Virtual reality platform
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality | Experimental | Participants electing to participate in the virtual reality based smoking cessation platform Receives: Device: MindCotine Virtual reality |
| Control | No intervention | Those utilizing standard of care smoking cessation therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment
Ability to recruit our target number of participants during the study period
Measured: 1 year
Adoptability
Adoption rate will be assess as those who complete at least 75% of the VR content compared to the total persons enrolled in the study
Measured: 1 year
Secondary outcomes (1)
efficacy of smoking cessation
percentage of persons who stopped smoking during the course of the study in the VR group compared to controls
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- MindCotine
- Responsible party
- Principal investigator, Sara Ghandehari, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021652
- Sponsor's protocol ID
- STUDY00002746
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Adoption and Efficacy of A Virtual Reality Smoking Cessation Program for Patients Undergoing Lung Cancer Screening: A Pilot Trial
- ClinicalTrials.gov ID
- NCT06021652
- Acronym / sponsor ID
- STUDY00002746
- Conditions
- Tobacco Use Cessation
- Keywords
- Tobacco use, Virtual Reality, Smoking cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- MindCotine
- Study start
- Sep 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Sep 2023 (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.
Lung cancer is the second most common cancer and the leading cause of cancer related deaths in the United States (US . Tobacco use is the leading cause of lung cancer and tobacco control continues to be the primary method of lung cancer prevention. Smoking cessation interventions (SCIs) are strongly recommended by screening guidelines and have a class A recommendation by the United States Preventive Services Task Force. Currently, a variety of smoking cessation interventions exist, and evidence suggests that pharmacotherapy, such as nicotine replacement therapy, in combination with behavioral interventions is more effective than either intervention alone. Many individuals, however, prefer not to use or are unable to use pharmacotherapy. A variety of behavioral interventions exist to aid in smoking cession. Recently, virtual reality (VR) has emerged as a possible tool to conduct behavior interventions. Previous research has demonstrated that use of VR can improve patient engagement in a variety of chronic disease interventions. Little is known however about the feasibility and adoption of VR in smoking cessation, especially among individuals at high risk for lung cancers. VR based platforms utilize 'cue exposure therapy'. Given that cravings are often triggered by external factors, or cues, cue exposure therapy exposes individuals to repeated drug-related cues and provides them with tools to eliminate cue-induced cravings. Given the inability for all individuals to use pharmacotherapy there remains a critical need to improve adherence to and efficacy of behavioral interventions for smoking cessation. To address this unmet need, the investigators propose, as pilot study, to enroll patients undergoing routine lung cancer screening and who are not interested in or cannot take pharmacologic therapies for smoking cession, to participate in VR based smoking cessation therapy.
Detailed description
The purpose of this study is to assess the adoption rate of VR smoking cessation intervention (MindCotine app) in those who are at risk for lung cancer and are participating in a lung cancer screening program.
The investigators will enroll 20 individuals. 10 of whom elect to participate in the VR program and 10 of whom are using standard of care smoking cessation methods.
The study duration is 90 days after completion of the MindCotine VR program. The MindCotine program consists of a 8-week training stage, and includes audiovisual content, cognitive behavioral therapy based self-reflective questions, setting a quit date, and notifications. The audio-visual content includes formal mindfulness exercises involving breathing techniques, body awareness, thought recognition, emotions, and smoking impulses. VR therapy exercises include the following topics: The Act of Smoking; RAIN meditation; Stress at work; Bodily sensations; Deep emotions; Nicotine anonymous; Alcohol as a trigger. Each content consists of a 2 minute animated environment to induce meditative states of mind, 6 minutes of exposure with real people, and 2 more minutes of an animated environment to induce a meditative mindset.
Participants will be surveyed at baseline, 1 day after the completion of the 8 week VR program and again 90 days after the completion of the VR program.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: MindCotine Virtual realityParticipants electing to participate in the virtual reality based smoking cessation platform |
| Control | No intervention | –Those utilizing standard of care smoking cessation therapies |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to read and understand informed consent
- Easy access to personal smartphone o Male or female adults who are at high risk for lung cancer and are enrolled in the Cedars-Sinai lung cancer screening program A: Based on USPSTF guidelines: Age 50-80 with 20 or greater pack-year smoking story who continue to smoke B: Based on National Comprehensive Cancer Network (NCCN) guidelines but do not meet the USPSTF guidelines, age 50-unlimited
Key exclusion criteria (3 listed)
- Persons with photosensitive epilepsy will be excluded; flashing scenes in the virtual reality can trigger seizures.
- Any records flagged "break the glass" or "research opt-out."
- Persons who are unable to use smart phone or have a smartphone that is not compatible with a virtual reality app. The app is currently available in English and Spanish, and those who are not fluent in speaking and reading English or Spanish are excluded from the study.
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 |
|---|---|---|
| MindCotine Virtual realityVirtual reality platform | Device | Virtual Reality |
Primary outcome
Feasibility of recruitment
Time frame: 1 year
Ability to recruit our target number of participants during the study period
Adoptability
Time frame: 1 year
Adoption rate will be assess as those who complete at least 75% of the VR content compared to the total persons enrolled in the study
1 secondary outcome
efficacy of smoking cessation
Time frame: 1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sara Ghandehari, MD contact
Questions about this trial
What is this clinical trial studying?
A study testing MindCotine Virtual reality in people with Tobacco Use Cessation, run by Cedars-Sinai Medical Center.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Divya Narayanan, MD (310-423-5242, divya.narayanan@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of recruitment (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2023.