CONNECT: Smoking Cessation and Lung Cancer Screening

Study Overview
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Brief Summary
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This clinical trial studies the impact of CONNECT on biochemically confirmed smoking abstinence among diverse current smokers who are undergoing lung cancer screening.

Detailed Description
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The study team will develop and test a novel smoking cessation intervention, CONNECT, which will start at the time an individual is receiving lung cancer screening (LCS). CONNECT will include an interactive Video Doctor which will provide participants with information tailored to their individual responses as well as proactive outreach using brief telephone calls and text messaging to follow up smokers with motivation enhancement to refer and engage patients in evidence based smoking cessation interventions (such as quitline utilization). After development and usability testing, we will conduct a small feasibility study followed by a pilot randomized controlled trial to estimate the impact of CONNECT on biochemically confirmed 30-day smoking abstinence among diverse current smokers seen at the San Francisco Veterans Affairs Medical Center and the University of California San Francisco Division of General Internal Medicine. Participants will be randomized to CONNECT or a control condition. Data will include self-report from participants obtained at baseline, 1 and 3 months, and the electronic health record. Outcomes will be biochemically confirmed 30-day smoking abstinence at 3 months post LCS and satisfaction as well as self-reported quit attempts, and use of evidence-based smoking cessation resources (quitline, pharmacotherapy or counseling). The knowledge gained will provide the pilot data necessary to apply for a larger study to test our novel intervention for promoting smoking cessation among a diverse population of high-risk smokers undergoing Lung Cancer Screening.

Official Title
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CONNECT: Smoking Cessation and Lung Cancer Screening

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: Computer-Assisted Intervention Video Doctor
* Other: Computer-Assisted Intervention no Video Doctor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 55-80 Male or female English speaking Have an already scheduled low-dose computed tomography (LDCT) visit Smoke at least 1 cigarette in the last 7 days Have a phone that can receive text messages. Exclusion Criteria: Younger than 55 or older than 80 Does not speak English Does not have a scheduled low-dose computed tomography (LDCT) visit Does not smoke at least 1 cigarette in the last 7 days Does not have a phone that can receive text messages.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Intervention Group (CONNECT)<br>Patients complete CONNECT, the Video Doctor over 30-45 minutes on an iPad in the waiting room before their lung cancer screening test appointment. | Other: Computer-Assisted Intervention Video Doctor<br>* Complete CONNECT: participants will undergo in-person assessment questions and follow-up assessment questions. They will view and participate in the interactive Video Doctor about Smoking Cessation.<br>|
| Active Comparator: Control Group<br>Patients complete CONNECT assessment only over 30-45 minutes on an iPad in the waiting room before their lung cancer screening test appointment. Individuals who are randomized to the control group will undergo the same assessment questions and all follow up assessments like the intervention group. Instead of viewing and participating in the interactive Video Doctor about Smoking Cessation, they receive a handout containing smoking cessation resources. | Other: Computer-Assisted Intervention no Video Doctor<br>* Individuals who are randomized to the control group will undergo the same assessment questions and all follow up assessments like the intervention group. Instead of viewing and participating in the interactive Video Doctor about Smoking Cessation, they receive a handout containing smoking cessation resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessing 30-day smoking abstinence at 3 months post lung cancer screening. | Biochemically confirmed 30-day smoking abstinence at 3 months post lung cancer screening. | Up to 3 months from date of lung cancer screening appointment. | 
| Number of participants with Self-reported quit attempts | Self-reported quit attempts will be measured to assess smoking behavioral changes. | Up to 3 months from date of lung cancer screening appointment. | 
| Percentage of participants who used of evidence-based smoking cessation resources | Use of evidence-based smoking cessation resources such as quitline, pharmacotherapy or counseling will be measured to assess smoking behavioral changes. | Up to 3 months from date of lung cancer screening appointment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Participation rate over time | Participation rate, including those who decline to participate and who drop out will be reported as proportions. The data will be compared between the two groups (intervention and control) using the appropriate general linear models with generalized estimating equations (GEE) to account for provider clusters. | Up to 18 months. | 
| Change in intervention component completion rates over time | Intervention component completion rates, including those who decline to participate and who drop out will be reported as proportions. The data will be compared between the two groups (intervention and control) using the appropriate general linear models with generalized estimating equations (GEE) to account for provider clusters. | Up to 18 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quitting, smoking, smoking cessation tool, smoking cessation, quit smoking, smoking cessation resources, smoking cessation barriers, smoking cessation intervention tool