Feasibility, Adoption and Efficacy of A Virtual Reality Smoking Cessation Program for Patients Undergoing Lung Cancer Screening

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Device: MindCotine Virtual reality

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Divya Narayanan, MD; Phone Number: 310-423-5242; Email: divya.narayanan@cshs.org
• Study Contact Backup: Name: Sara Ghandehari, MD; Email: sara.ghandehair@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Participants electing to participate in the virtual reality based smoking cessation platform	Device: MindCotine Virtual reality; Virtual reality platform
No Intervention: Control; Those utilizing standard of care smoking cessation therapies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment	Ability to recruit our target number of participants during the study period	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of smoking cessation	percentage of persons who stopped smoking during the course of the study in the VR group compared to controls	1year

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: MindCotine

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 28, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 23, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Smoking cessation; Virtual Reality; Tobacco use
• Other Study ID Numbers: STUDY00002746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No