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Completed

NCT Number: NCT04149249

CONNECT: Smoking Cessation and Lung Cancer Screening

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

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Veterans Affairs Medical Center, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computer-Assisted Intervention Video Doctor

Other

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.

Computer-Assisted Intervention no Video Doctor

Other

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 outcomes

  1. Assessing 30-day smoking abstinence at 3 months post lung cancer screening.

    Time frame: Up to 3 months from date of lung cancer screening appointment.

    Biochemically confirmed 30-day smoking abstinence at 3 months post lung cancer screening.

  2. Number of participants with Self-reported quit attempts

    Time frame: Up to 3 months from date of lung cancer screening appointment.

    Self-reported quit attempts will be measured to assess smoking behavioral changes.

  3. Percentage of participants who used of evidence-based smoking cessation resources

    Time frame: 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 outcomes

  1. Change in Participation rate over time

    Time frame: 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.

  2. Change in intervention component completion rates over time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • San Francisco Veterans Affairs Medical Center
  • Tobacco Related Disease Research Program

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2019
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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