CONNECT: Smoking Cessation and Lung Cancer Screening

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Other: Computer-Assisted Intervention Video Doctor; Other: Computer-Assisted Intervention no Video Doctor

• Registration Number: NCT04149249
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-08-21
• Study First Submitted: 2019-10-09
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-04
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Intervention Group (CONNECT)	Computer-Assisted Intervention Video Doctor	Patients complete CONNECT, the Video Doctor over 30-45 minutes on an iPad in the waiting room before their lung cancer screening test appointment.
Control Group	Computer-Assisted Intervention no Video Doctor	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in intervention component completion rates over time	Up to 18 months.	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.
Change in Participation rate over time	Up to 18 months.	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.

Trial Locations

Locations (2)

San Francisco Veterans Affairs Medical Center; 🇺🇸 San Francisco, California, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States