xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06021652</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00002746</org_study_id>
      <nct_id>NCT06021652</nct_id>
    </id_info>
    <brief_title>Feasibility, Adoption and Efficacy of A Virtual Reality Smoking Cessation Program for Patients Undergoing Lung Cancer Screening: A Pilot Trial</brief_title>
    <official_title>Feasibility, Adoption and Efficacy of A Virtual Reality Smoking Cessation Program for Patients Undergoing Lung Cancer Screening: A Pilot Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cedars-Sinai Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>MindCotine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cedars-Sinai Medical Center</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Lung cancer is the second most common cancer and the leading cause of cancer related deaths&#xD;
        in the United States (US . Tobacco use is the leading cause of lung cancer and tobacco&#xD;
        control continues to be the primary method of lung cancer prevention. Smoking cessation&#xD;
        interventions (SCIs) are strongly recommended by screening guidelines and have a class A&#xD;
        recommendation by the United States Preventive Services Task Force. Currently, a variety of&#xD;
        smoking cessation interventions exist, and evidence suggests that pharmacotherapy, such as&#xD;
        nicotine replacement therapy, in combination with behavioral interventions is more effective&#xD;
        than either intervention alone. Many individuals, however, prefer not to use or are unable to&#xD;
        use pharmacotherapy. A variety of behavioral interventions exist to aid in smoking cession.&#xD;
        Recently, virtual reality (VR) has emerged as a possible tool to conduct behavior&#xD;
        interventions. Previous research has demonstrated that use of VR can improve patient&#xD;
        engagement in a variety of chronic disease interventions. Little is known however about the&#xD;
        feasibility and adoption of VR in smoking cessation, especially among individuals at high&#xD;
        risk for lung cancers. VR based platforms utilize 'cue exposure therapy'. Given that cravings&#xD;
        are often triggered by external factors, or cues, cue exposure therapy exposes individuals to&#xD;
        repeated drug-related cues and provides them with tools to eliminate cue-induced cravings.&#xD;
        Given the inability for all individuals to use pharmacotherapy there remains a critical need&#xD;
        to improve adherence to and efficacy of behavioral interventions for smoking cessation. To&#xD;
        address this unmet need, we propose, as pilot study, to enroll patients undergoing routine&#xD;
        lung cancer screening and who are not interested in or cannot take pharmacologic therapies&#xD;
        for smoking cession, to participate in VR based smoking cessation therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to assess the adoption rate of VR smoking cessation intervention&#xD;
        (MindCotine app) in those who are at risk for lung cancer and are participating in a lung&#xD;
        cancer screening program.&#xD;
  &#xD;
        We will enroll 20 individuals. 10 of whom elect to participate in the VR program and 10 of&#xD;
        whom are using standard of care smoking cessation methods.&#xD;
  &#xD;
        The study duration is 90 days after completion of the MindCotine VR program. The MindCotine&#xD;
        program consists of a 8-week training stage, and includes audiovisual content, cognitive&#xD;
        behavioral therapy based self-reflective questions, setting a quit date, and notifications.&#xD;
        The audio-visual content includes formal mindfulness exercises involving breathing&#xD;
        techniques, body awareness, thought recognition, emotions, and smoking impulses. VR therapy&#xD;
        exercises include the following topics: The Act of Smoking; RAIN meditation; Stress at work;&#xD;
        Bodily sensations; Deep emotions; Nicotine anonymous; Alcohol as a trigger. Each content&#xD;
        consists of a 2 minute animated environment to induce meditative states of mind, 6 minutes of&#xD;
        exposure with real people, and 2 more minutes of an animated environment to induce a&#xD;
        meditative mindset.&#xD;
  &#xD;
        Participants will be surveyed at baseline, 1 day after the completion of the 8 week VR&#xD;
        program and again 90 days after the completion of the VR program.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility of recruitment</measure>
      <time_frame>1 year</time_frame>
      <description>Ability to recruit our target number of participants during the study period</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Adoptability</measure>
      <time_frame>1 year</time_frame>
      <description>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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>efficacy of smoking cessation</measure>
      <time_frame>1year</time_frame>
      <description>percentage of persons who stopped smoking during the course of the study in the VR group compared to controls</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Tobacco Use Cessation</condition>
    <arm_group>
      <arm_group_label>Virtual Reality</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants electing to participate in the virtual reality based smoking cessation platform</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Those utilizing standard of care smoking cessation therapies</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MindCotine Virtual reality</intervention_name>
      <description>Virtual reality platform</description>
      <arm_group_label>Virtual Reality</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to read and understand informed consent&#xD;
  &#xD;
            -  Easy access to personal smartphone o Male or female adults who are at high risk for&#xD;
               lung cancer and are enrolled in the Cedars-Sinai lung cancer screening program A:&#xD;
               Based on USPSTF guidelines: Age 50-80 with 20 or greater pack-year smoking story who&#xD;
               continue to smoke B: Based on National Comprehensive Cancer Network (NCCN) guidelines&#xD;
               but do not meet the USPSTF guidelines, age 50-unlimited&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Persons with photosensitive epilepsy will be excluded; flashing scenes in the virtual&#xD;
               reality can trigger seizures.&#xD;
  &#xD;
            -  Any records flagged &quot;break the glass&quot; or &quot;research opt-out.&quot;&#xD;
  &#xD;
            -  Persons who are unable to use smart phone or have a smartphone that is not compatible&#xD;
               with a virtual reality app. The app is currently available in English and Spanish, and&#xD;
               those who are not fluent in speaking and reading English or Spanish are excluded from&#xD;
               the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Divya Narayanan, MD</last_name>
      <phone>310-423-5242</phone>
      <email>divya.narayanan@cshs.org</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sara Ghandehari, MD</last_name>
      <email>sara.ghandehair@cshs.org</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
      <investigator_full_name>Sara Ghandehari</investigator_full_name>
      <investigator_title>Professor of Medicine, Division of Pulmonary and Critical Care Medicine</investigator_title>
    </responsible_party>
    <keyword>Tobacco use, Virtual reality, tobacco cessation</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06021652
  org study id: STUDY00002746
  nct id: NCT06021652
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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, we 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.
  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.
  
        We 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.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Feasibility of recruitment
  time frame: 1 year
  description: Ability to recruit our target number of participants during the study period
  measure: Adoptability
  time frame: 1 year
  description: 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
  measure: efficacy of smoking cessation
  time frame: 1year
  description: percentage of persons who stopped smoking during the course of the study in the VR group compared to controls
  arm group label: Virtual Reality
  arm group type: Experimental
  description: Participants electing to participate in the virtual reality based smoking cessation platform
  arm group label: Control
  arm group type: No Intervention
  description: Those utilizing standard of care smoking cessation therapies
  intervention type: Device
  intervention name: MindCotine Virtual reality
  description: Virtual reality platform
  arm group label: Virtual Reality
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Divya Narayanan, MD
  phone: 310-423-5242
  email: divya.narayanan@cshs.org
  last name: Sara Ghandehari, MD
  email: sara.ghandehair@cshs.org
  responsible party type: Principal Investigator
  investigator affiliation: Cedars-Sinai Medical Center
  investigator full name: Sara Ghandehari
  investigator title: Professor of Medicine, Division of Pulmonary and Critical Care Medicine
  sharing ipd: No