Recruiting

CONNECT ML

Sponsor:

UCLA

Code:

NCT07111936

Conditions

Smoking Cessation

Smoking Cessation Counseling Ability and Practice

Smoking Cessation Counselling

Lung Cancer Screening

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Interventions

CONNECT Intervention for multilingual populations

Saliva Sample

Interview

Study Details

Brief summary:

This study aims to broaden the reach of the lung cancer screening (LCS) CONNECT program (NCT04149249, NCT06213532), by developing a version of the program to be available to multilingual communities. The CONNECT program encourages individuals who are undergoing lung cancer screening to also quit smoking by providing a personalized program which includes a video doctor with personalized responses, text message and telephone call support and connection with a pharmacist to assist in obtaining nicotine replacement medication. This clinical trial will develop and ultimately test how well the CONNECT Multilingual (CONNECT ML) program works to improve smoking cessation among current adult smokers within the Spanish and Cantonese speaking communities.

Conditions

Smoking Cessation

Smoking Cessation Counseling Ability and Practice

Smoking Cessation Counselling

Lung Cancer Screening

Study ID

NCT07111936

Start date

Aug 7, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 50-80 years old.
  • Current smokers defined at smoking at least one cigarette in past 7 days AND eligible for lung cancer screening (LCS) based on smoking history (>=20 pack year history)
  • California (CA) residents
  • Able to understand and comply with study procedures for the entire length of the study.
  • Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

  • Non-smokers.
  • Individuals with a diagnosis of lung cancer.
  • Individuals receiving hospice care.
  • Individuals whose providers do not think that they should participate (e.g., psychiatric illness or significant cognitive impairment that would impede the individuals ability to participate).
  • Hearing and/or vision disabilities that would prevent participants from adequately receiving treatment components such as video or telephone counseling.

Study Design

Enrollment

439 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Focus Group

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.

active comparator: Beta Group

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.

experimental: Group 1: CONNECT Multi-lingual intervention

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

experimental: Group 2: Control Group

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.

Interventions

CONNECT Intervention for multilingual populations

The program includes interactive Video Doctor visits to provide participants with information tailored to their individual responses and outreach via brief telephone calls and text messaging to follow-up and connect smokers with evidence-based resources for smoking cessation.

Saliva Sample

Undergo saliva collection

Interview

Attend a focus group

Primary outcome measure

  • Percentage of participants Smoking cessation rates (Randomized groups only) [ Time Frame: Up to 6 months ]
  • Mean number of quit attempts over time (Randomized groups only) [ Time Frame: Up to 6 months ]
  • Percentage of participants who reported use of smoking cessation resources (Randomized groups only) [ Time Frame: Up to 6 months ]

Central Contacts and Locations

Central contacts

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Judith Walsh, MD, MPH

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • Multilingual

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-08-13.