CONNECT: Smoking Cessation and Lung Cancer Screening

Smoking Cessation Clinical Trial

Official title:

CONNECT: Smoking Cessation and Lung Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04149249
• Other study ID #: 18-25632
• Secondary ID: NCI-2018-0388418
• Status: Completed
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies the impact of CONNECT on biochemically confirmed smoking abstinence among diverse current smokers who are undergoing lung cancer screening.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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.
• 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.

Locations

Country	Name	City	State
United States	San Francisco Veterans Affairs Medical Center	San Francisco	California
United States	University of California, San Francisco	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	San Francisco Veterans Affairs Medical Center, Tobacco Related Disease Research Program

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing 30-day smoking abstinence at 3 months post lung cancer screening.	Biochemically confirmed 30-day smoking abstinence at 3 months post lung cancer screening.	Up to 3 months from date of lung cancer screening appointment.
Primary	Number of participants with Self-reported quit attempts	Self-reported quit attempts will be measured to assess smoking behavioral changes.	Up to 3 months from date of lung cancer screening appointment.
Primary	Percentage of participants who used of evidence-based smoking cessation resources	Use of evidence-based smoking cessation resources such as quitline, pharmacotherapy or counseling will be measured to assess smoking behavioral changes.	Up to 3 months from date of lung cancer screening appointment.
Secondary	Change in Participation rate over time	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.	Up to 18 months.
Secondary	Change in intervention component completion rates over time	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.	Up to 18 months.