Clinical trial NCT04149249: CONNECT: Smoking Cessation and Lung Cancer Screening
Official title: CONNECT: Smoking Cessation and Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: quitting
smoking
smoking cessation tool
smoking cessation
quit smoking
smoking cessation resources
smoking cessation barriers
smoking cessation intervention tool
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Tobacco Related Disease Research Program
name: San Francisco Veterans Affairs Medical Center
First posted: 2019-11-04
Enrollment: 99
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Assessing 30-day smoking abstinence at 3 months post lung cancer screening.
timeFrame: Up to 3 months from date of lung cancer screening appointment.
measure: Number of participants with Self-reported quit attempts
timeFrame: Up to 3 months from date of lung cancer screening appointment.
measure: Percentage of participants who used of evidence-based smoking cessation resources
timeFrame: Up to 3 months from date of lung cancer screening appointment.
Secondary outcomes:
measure: Change in Participation rate over time
timeFrame: Up to 18 months.
measure: Change in intervention component completion rates over time
timeFrame: Up to 18 months.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Judith Walsh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):515-523. doi: 10.3109/00016341003678419.
citation: 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.
citation: 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. doi: 10.1016/j.lungcan.2003.10.001.
citation: 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.
citation: 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.