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CONNECT: Smoking Cessation and Lung Cancer Screening

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ClinicalTrials.gov Identifier: NCT04149249
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborators:
Tobacco Related Disease Research Program
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE October 9, 2019
First Posted Date  ICMJE November 4, 2019
Last Update Posted Date November 4, 2019
Actual Study Start Date  ICMJE August 21, 2019
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
  • Assessing 30-day smoking abstinence at 3 months post lung cancer screening. [ Time Frame: Three months from date of lung cancer screening appointment. ]
    The primary outcome will be biochemically confirmed 30-day smoking abstinence at 3 months post lung cancer screening.
  • Self-reported smoking behavior changes [ Time Frame: Three months from date of lung cancer screening appointment. ]
    Additional outcomes will include self-reported quit attempts, use of evidence-based smoking cessation resources (quitline, pharmacotherapy or counseling).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2019)
Analyzing statistics of frequency counts and proportions of the feasibility measures. [ Time Frame: Baseline up to 18 months. ]
The secondary outcomes will be descriptive statistics of frequency counts and proportions of the feasibility measures (participation rate, intervention component completion rates), including those who decline to participate and who drop out. The feasibility and acceptability 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CONNECT: Smoking Cessation and Lung Cancer Screening
Official Title  ICMJE CONNECT: Smoking Cessation and Lung Cancer Screening
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • Other: Computer-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.
  • Other: Computer-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.
Study Arms  ICMJE
  • Experimental: Experimental: Intervention Group (CONNECT)
    Patients complete CONNECT, the Video Doctor over 30-45 minutes on an iPad in the waiting room before their lung cancer screening test appointment.
    Intervention: Other: Computer-Assisted Intervention Video Doctor
  • Active Comparator: Control Group

    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.

    Intervention: Other: Computer-Assisted Intervention no Video Doctor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 31, 2019)
128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04149249
Other Study ID Numbers  ICMJE 18-25632
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE
  • Tobacco Related Disease Research Program
  • San Francisco Veterans Affairs Medical Center
Investigators  ICMJE
Principal Investigator: Judith Walsh, MD, MPH UCSF Professor, Division of General Internal Medicine
PRS Account University of California, San Francisco
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP