Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06021652 |
| Other study ID # |
STUDY00002746 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2023 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Cedars-Sinai Medical Center |
| Contact |
Divya Narayanan, MD |
| Phone |
310-423-5242 |
| Email |
divya.narayanan[@]cshs.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
