Low Dose Computed Tomography for Lung Cancer Screening

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.

Detailed Description
-----------------
Using a 3-arm randomized trial design with repeated measures at 1, 3, 6, and 12 months, the study will randomize N=1650 smokers who present for LDCT lung cancer screening to an passive referral usual care control condition, proactive referral to a digital cessation intervention that combines web and text messaging, or proactive referral to a digital cessation intervention combined with Tobacco Treatment Specialist counseling. The Study will examine overall effectiveness of the interventions in promoting abstinence, the impact of proactive referral to treatment, and the total cost and cost effectiveness of the interventions. The Study will also examine the representativeness of the enrolled sample and explore barriers and facilitators to intervention adoption with LDCT clinic leaders. The trial is structured as a practical clinical trial to answer key questions of direct relevance to LDCT decision-makers.

Official Title
-----------------
Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: Usual Care
* Behavioral: WEB+TXT
* Behavioral: WEB+TXT+TTS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for LDCT screening Current smoking (every day/some days) At least weekly use of the Internet Current ownership of cell phone with a text messaging plan Willing to receive study text messages. Ability to complete all aspects of the study Ability to provide signed informed consent Exclusion Criteria: Current (in the past 30 days) use of tobacco cessation medication or participation in tobacco cessation treatment. Those with a condition deemed by the investigators to be exclusionary to the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: UC<br>Usual Care | Behavioral: Usual Care<br>* Brief cessation counseling<br>|
| Active Comparator: WEB+TXT<br>Digital Intervention | Behavioral: WEB+TXT<br>* Access to Become an Ex website plus text messaging<br>|
| Active Comparator: WEB+TXT+TTS<br>Digital plus Counseling Intervention | Behavioral: WEB+TXT+TTS<br>* Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking abstinence | biochemically confirmed 12 month smoking abstinence of WEB+TXT; | 12 months | 
| smoking abstinence | biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ; | 12 months | 
| smoking abstinence | biochemically confirmed 12 month smoking abstinence of UC; | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tobacco, smoking, low dose computed tomography, lung screening, text messaging