Smoking Cessation
Conditions
Keywords
quitting, smoking, smoking cessation tool, smoking cessation, quit smoking, smoking cessation resources, smoking cessation barriers, smoking cessation intervention tool
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.
Interventions
OTHERComputer-Assisted Intervention Video Doctor
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.
OTHERComputer-Assisted Intervention no Video Doctor
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.
Sponsors
Tobacco Related Disease Research Program
San Francisco Veterans Affairs Medical Center
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed