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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 : August 11, 2021
Sponsor:
Collaborators:
Tobacco Related Disease Research Program
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Computer-Assisted Intervention Video Doctor Other: Computer-Assisted Intervention no Video Doctor Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: CONNECT: Smoking Cessation and Lung Cancer Screening
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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.
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04149249


Contacts
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Contact: Judith Walsh, MD, MPH 415-353-9747 Judith.Walsh@ucsf.edu

Locations
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United States, California
San Francisco Veterans Affairs Medical Center Recruiting
San Francisco, California, United States, 94121
Contact: James Brown, MD    415-221-4810    James.Brown@ucsf.edu   
Contact: Neil Trivedi, MD    415-221-4810    Neil.Trivedi@ucsf.edu   
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Judith Reynolds, MD, MPH    415-353-9747    Judith.Walsh@ucsf.edu   
Contact    877-827-3222    cancertrials@ucsf.edu   
Principal Investigator: Judith M. Walsh, MD, MPH         
Sponsors and Collaborators
University of California, San Francisco
Tobacco Related Disease Research Program
San Francisco Veterans Affairs Medical Center
Investigators
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Principal Investigator: Judith Walsh, MD, MPH University of California, San Francisco
More Information
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Publications:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04149249    
Other Study ID Numbers: 18-25632
NCI-2018-03884 ( Registry Identifier: NCI Clinical Trials Reporting Program (CTRP) )
186515 ( Other Identifier: University of California, San Francisco )
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
quitting
smoking
smoking cessation tool
smoking cessation
 quit smoking
smoking cessation resources
smoking cessation barriers
smoking cessation intervention tool