Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation

Study Overview
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Brief Summary
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This study aims to see how feasible a mobile app based virtual reality program for smoking cessation (MindCotine) would be among Stanford cancer center patients

Official Title
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Stanford Tobacco Treatment Services - Virtual Reality Treatment for Smoking Cessation

Conditions
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Smoking Cessation, MindCotine Virtual Reality Mindful Exposure Therapy

Intervention / Treatment
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* Behavioral: MindCotine's VR app


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Daily cigarette smoker or some day smoker (>9 cigarettes per week) Age 18+ English or Spanish fluent Smartphone compatibility Available to interact with a smartphone app for 6-weeks Available to complete the EOT assessment at end of 6-weeks Ability to understand and the willingness to personally sign the written IRB-approved informed consent document. Confirm phone, email, address during consent Exclusion Criteria: Ever had epilepsy Less than 10 cigarettes per week Not English or Spanish fluent No smartphone compatibility Unavailable to interact with the VR program, Unavailable to answer questions about the intervention post-treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MindCotine mobile app program<br> | Behavioral: MindCotine's VR app<br>* The MindCotine program would be a 6-week intervention to help users utilize mindfulness based skills, and involves virtual exposure therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Registered With the MindCotine Application | Total number of patients who registered with the app, out of total number of participants who were enrolled (eligible and willing to accept help with quitting). This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. | 6 weeks | 
| Number of Patients With Interest in the MindCotine Application | Total number of patients who expressed interest in the app, out of total number of participants who were screened for enrollment. This measure is to assess whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. | 6 weeks | 
| Number of Patients Who Would Recommend the MindCotine Application as a Measure of Feasibility Among Patients Who Smoke. | Learning whether MindCotine is a feasible smoking cessation option among patients who smoke cigarettes. Interest in using the app will be calculated as total number of patients who recommend the app to others. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Attempt to Quit Smoking by Using the Application | Measured as the number of participants who had a 24-hour quit attempt in the past 6-weeks prior to end of treatment survey | 6 weeks prior to end of treatment survey | 
| Number of Patients Using Cessation Medication by End of Treatment | Number of participants using cessation medications among those who completed the end of treatment survey. | 6 weeks | 
| Number of MindCotine App Program Activities Completed | Program activities include VR-MET exercises and guided mindfulness-based two-dimensional video, audio, and reflection exercises. | 6 weeks | 
| Number of MindCotine App Journal Entries Completed | Journal Record refers to CBT-based self-reflections. | 6 weeks | 
| Number of MindCotine App Coaching Engagements Completed | Coaching Engagement refers to communicating with a coach through the MindCotine mobile application. | 6 weeks | 
| Average Change in Cigarette Use | Average change in cigarette use from baseline to end of treatment among patients using the MindCotine app. | baseline to end of treatment, up to 6 weeks | 
| MindCotine Dropout | Number of patients who withdrew or were removed from the study. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Smoking Cessation