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

NCT06021652 | Unknown

• 1 other identifier: STUDY00002746
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tobacco Use Cessation

Keywords

Tobacco use; Virtual Reality; Smoking cessation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• efficacy of smoking cessation

  1year

Study Arms (2)

Virtual Reality

EXPERIMENTAL

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

Device: MindCotine Virtual reality

Control

NO INTERVENTION

Those utilizing standard of care smoking cessation therapies

Interventions

MindCotine Virtual reality DEVICE

Virtual reality platform

Virtual Reality

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• MindCotine: collaborator

MeSH Terms

Conditions

Tobacco Use Cessation; Tobacco Use; Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Central Study Contacts

Divya Narayanan, MD

CONTACT

310-423-5242; divya.narayanan@cshs.org

Sara Ghandehari, MD

CONTACT

sara.ghandehair@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Division of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 1, 2023
• Study Start: September 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share