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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking Cessation | Other: Computer-Assisted Intervention Video Doctor Other: Computer-Assisted Intervention no Video Doctor | Not Applicable |
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, 2020 |
Estimated Study Completion Date : | June 30, 2020 |

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.
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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. |
- 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).
- 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.

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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 |
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.

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
United States, California | |
UCSF Medical Center-Mount Zion | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Judith M. Walsh 415-353-9747 judith.walsh@ucsf.edu | |
Principal Investigator: Judith M. Walsh | |
San Francisco Veterans Affairs Medical Center | Recruiting |
San Francisco, California, United States, 94122 | |
Contact: James Brown, MD 415-221-4810 james.brown@ucsf.edu | |
Contact: Neil Trivedi, MD 415-221-4810 Neil.Trivedi@ucsf.edu |
Principal Investigator: | Judith Walsh, MD, MPH | UCSF Professor, Division of General Internal Medicine |
Publications:
Responsible Party: | University of California, San Francisco |
ClinicalTrials.gov Identifier: | NCT04149249 History of Changes |
Other Study ID Numbers: |
18-25632 |
First Posted: | November 4, 2019 Key Record Dates |
Last Update Posted: | November 4, 2019 |
Last Verified: | October 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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