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Clinical Trials/NCT04149249
NCT04149249
Completed
Not Applicable

CONNECT: Smoking Cessation and Lung Cancer Screening

University of California, San Francisco2 sites in 1 country99 target enrollmentAugust 21, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
University of California, San Francisco
Enrollment
99
Locations
2
Primary Endpoint
Assessing 30-day smoking abstinence at 3 months post lung cancer screening.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 21, 2019
End Date
May 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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.

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

  • Change in intervention component completion rates over time(Up to 18 months.)
  • Change in Participation rate over time(Up to 18 months.)

Study Sites (2)

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