CONNECT Intervention for Lung Cancer Screening

(CONNECT-ML Trial)

Overseen By Anita Ponce, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Lung cancer, Hospice care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist Spanish and Cantonese-speaking smokers in quitting smoking during lung cancer screening. It tests the CONNECT Intervention for multilingual populations, a personalized program featuring interactive video sessions with a virtual doctor, supportive text messages, phone calls, and access to a pharmacist for nicotine replacement medications. Participants include California residents who smoke and qualify for lung cancer screening. The trial will collect feedback from participants to refine the program and assess its effectiveness. As an unphased trial, this study provides participants the chance to contribute to innovative research that could improve smoking cessation support for diverse communities.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on smoking cessation support, so it's best to discuss your medications with the trial team or your doctor.

What prior data suggests that the CONNECT Intervention for multilingual populations is safe?

Studies have shown that participants generally find the CONNECT program easy to handle. This program helps people quit smoking by offering personalized support through videos, text messages, and phone calls. Participants can also consult a pharmacist about using nicotine replacement therapy, a common method to aid smoking cessation.

No major reports of negative effects have been linked to the CONNECT program. Since it focuses on providing support rather than introducing a new drug or medical device, it is considered safe. The CONNECT program has undergone testing, and its methods have proven safe and effective in helping people quit smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The CONNECT intervention for lung cancer screening is unique because it offers a multilingual approach to smoking cessation, which is not typically found in standard treatments like nicotine replacement therapy or prescription medications such as varenicline and bupropion. Researchers are excited about this trial because it includes an innovative blend of interactive video interventions, weekly text messages, and personalized counseling calls, all tailored to different languages. This approach not only makes quitting smoking more accessible to diverse populations but also integrates direct pharmacist support, potentially increasing the effectiveness of quitting efforts and addressing a wider range of smoking cessation barriers.

What evidence suggests that the CONNECT Intervention for multilingual populations could be effective for smoking cessation?

Research has shown that personalized programs like the CONNECT program, which participants in this trial may receive, can help people quit smoking. Studies have found that a combination of text messages, video support, and assistance from pharmacists increases the chances of quitting. The CONNECT program, part of this trial's lung cancer screening intervention, includes these tools to assist smokers who want to stop. Early results suggest that tailoring support to each person's needs enhances effectiveness. Additionally, reaching out to communities that speak different languages makes the program more effective by increasing accessibility. ^{1 2 3 5 6}

Who Is on the Research Team?

Judith Walsh, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adult smokers in Spanish and Cantonese speaking communities who are participating in lung cancer screening. It's designed to help them quit smoking using the CONNECT Multilingual program, which includes a video doctor, messaging support, and pharmacist assistance for nicotine replacement.

Inclusion Criteria

I currently smoke and have a history of 20 or more pack-years.

California (CA) residents

I am between 50 and 80 years old.

Exclusion Criteria

Individuals receiving hospice care

Non-smokers

My doctor thinks I am not fit for this trial due to mental health or cognitive issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group

Participants in the focus group will be interviewed by the study staff and discuss barriers and facilitators to smoking cessation

1-2 weeks

1 visit (in-person)

Beta Testing

Participants will be testing the CONNECT multilingual smoking cessation materials and provide feedback to investigators

1-2 weeks

1 visit (in-person)

Randomized Controlled Trial

Participants receive either the CONNECT Multilingual intervention or usual care, followed up at 1-week, 1-, 3-, and 6-months

6 months

4 follow-up visits (virtual)

Follow-up

Participants are monitored for smoking cessation rates and utilization of resources

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CONNECT Intervention for multilingual populations

Trial Overview The study tests the effectiveness of the CONNECT ML program in aiding smoking cessation among multilingual populations. Participants will receive personalized support through videos, texts, calls, and pharmacy services as part of their lung cancer screening process.

How Is the Trial Designed?

Group I: Group 2: Control Group Experimental Treatment 1 Intervention

Participants will receive usual care for smoking cessation at routine medical visit and be asked to complete a total of four brief follow-up phone surveys. Participants will be asked to provide a saliva sample at the end of the study.

Group II: Group 1: CONNECT Multi-lingual intervention Experimental Treatment 2 Interventions

Participants receive the CONNECT multilingual smoking cessation intervention finalized in the beta group analysis, that includes multi-lingual interactive video doctor intervention, text messages once weekly for 12 weeks, and several telephone counseling calls. Participants also receive access to a pharmacist to receive counseling about quitting smoking and may prescribe nicotine replacement therapy. Participants will be asked to provide a saliva sample at the end of the study

Group III: Focus Group Experimental Treatment 1 Intervention

Participants in the focus group will be interviewed by the study staff and discuss barriers and facilitators to smoking cessation to be implemented in the beta and randomized phases of the study.

Group IV: Beta Group Active Control 1 Intervention

Participants will be testing the CONNECT multilingual smoking cessation materials and provide feedback to investigators. Participation will be limited to about 1.5 - 2 hours.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07111936

Evaluating the Impact of CONNECT in a Multilingual ... The CONNECT program encourages individuals who are undergoing lung cancer screening to also quit smoking by providing a personalized program which includes a ...

2. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07111936

CONNECT in a Multilingual Population This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation ...

3. withpower.com withpower.com/trial/phase-smoking-cessation-2026-522f1

CONNECT Intervention for Lung Cancer Screening ... This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation among current ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6739236/

Smoking Cessation Interventions for Potential Use in the ... We conducted a systematic review and meta-analysis of current literature on the efficacy of smoking cessation interventions among populations eligible for LCS.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666364323000085

Interventions Designed to Increase the Uptake of Lung ... Interventions that were most effective in improving access to LCS targeted priority populations, raised community-level awareness, tailored materials for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8867367/

Comparing Smoking Cessation Interventions among ... The primary outcome is biochemically confirmed smoking abstinence sustained through 6 months. Secondary outcomes include abstinence sustained through 12 months, ...