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

NCT ID: NCT06021652

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-12-31

Brief 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. 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.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual Reality

Participants electing to participate in the virtual reality based smoking cessation platform

Group Type: EXPERIMENTAL

MindCotine Virtual reality

Intervention Type: DEVICE

Virtual reality platform

Control

Those utilizing standard of care smoking cessation therapies

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

MindCotine Virtual reality

Virtual reality platform

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MindCotine

UNKNOWN

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sara Ghandehari

Professor of Medicine, Division of Pulmonary and Critical Care Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Divya Narayanan, MD

Role: CONTACT

divya.narayanan@cshs.org

310-423-5242

Sara Ghandehari, MD

Role: CONTACT

sara.ghandehair@cshs.org

Other Identifiers

STUDY00002746

Identifier Type: -

Identifier Source: org_study_id