CONNECT: Smoking Cessation and Lung Cancer Screening

• ClinicalTrials.gov Identifier: NCT04149249
• Recruitment Status: Recruiting
• First Posted: November 4, 2019
• Last Update Posted: November 4, 2019
• Sponsor: University of California, San Francisco
• 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: October 9, 2019
• First Posted Date: November 4, 2019
• Last Update Posted Date: November 4, 2019
• Actual Study Start Date: August 21, 2019
• Estimated Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: CONNECT: Smoking Cessation and Lung Cancer Screening
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Other
• Condition: Smoking Cessation

Intervention

• 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

• 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 *

• Tsoh JY, Kohn MA, Gerbert B. Promoting smoking cessation in pregnancy with Video Doctor plus provider cueing: a randomized trial. Acta Obstet Gynecol Scand. 2010;89(4):515-23. doi: 10.3109/00016341003678419.
• van der Aalst CM, de Koning HJ, van den Bergh KA, Willemsen MC, van Klaveren RJ. The effectiveness of a computer-tailored smoking cessation intervention for participants in lung cancer screening: a randomised controlled trial. Lung Cancer. 2012 May;76(2):204-10. doi: 10.1016/j.lungcan.2011.10.006. Epub 2011 Nov 4.
• Clark MM, Cox LS, Jett JR, Patten CA, Schroeder DR, Nirelli LM, Vickers K, Hurt RD, Swensen SJ. Effectiveness of smoking cessation self-help materials in a lung cancer screening population. Lung Cancer. 2004 Apr;44(1):13-21.
• Marshall HM, Courtney DA, Passmore LH, McCaul EM, Yang IA, Bowman RV, Fong KM. Brief Tailored Smoking Cessation Counseling in a Lung Cancer Screening Population is Feasible: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2016 Jul;18(7):1665-9. doi: 10.1093/ntr/ntw010. Epub 2016 Feb 1.
• Ferketich AK, Otterson GA, King M, Hall N, Browning KK, Wewers ME. A pilot test of a combined tobacco dependence treatment and lung cancer screening program. Lung Cancer. 2012 May;76(2):211-5. doi: 10.1016/j.lungcan.2011.10.011. Epub 2011 Nov 15.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: October 31, 2019): 128
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2020
• Estimated Primary Completion Date: June 30, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04149249
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: University of California, San Francisco
• Study Sponsor: University of California, San Francisco

Collaborators

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

Investigators

• Principal Investigator: Judith Walsh, MD, MPH; UCSF Professor, Division of General Internal Medicine

• PRS Account: University of California, San Francisco
• Verification Date: October 2019