Evaluating the Impact of CONNECT in a Multilingual Population

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation; Smoking Cessation Counseling Ability and Practice; Smoking Cessation Counselling; Lung Cancer Screening

• Registration Number: NCT07111936
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Culturally adapt, translate, improve and fine tune the multi-faceted CONNECT program for multilingual smokers

II. Evaluate the CONNECT multilingual program for current smokers in multilingual communities.

III. Assess the impact of the CONNECT Multilingual program on smoking cessation rates and participant utilization of evidence-based resources to help quit smoking

OUTLINE:

FOCUS GROUP (N=24):

Three focus groups, one each with English, Spanish and Cantonese speaking participants (8 in each group) will be led by investigators. Interviews will be recorded, transcribed and translated. Translation of the Spanish and Cantonese transcripts will be done by University of California, San Francisco (UCSF) translation services.

BETA GROUP (N=15):

The investigators will conduct a pilot, beta testing of the intervention materials with English, Spanish and Cantonese speaking participants. Additional feedback and input from the participants will be used to fine tune the CONNECT smoking cessation intervention to be implemented in a randomized trial.

RANDOMIZED CONTROLLED TRIAL (N=400):

Newly enrolled participants will be assigned to 1 of 2 conditions.

* Group 1: Participants receive the CONNECT Multilingual intervention. Participants will be followed up at 1-week, 1-, 3-, and 6-months after treatment assignment. At 6-months, participants will be asked to complete and return an at-home saliva kit to verify their smoking status.

* Group 2: Participants receive usual care from providers at a regular primary care appointment. Participants will be followed up at 1-week, 1-, 3-, and 6-months after treatment assignment.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-01
• Study First Submitted QC: 2025-08-01
• Study First Posted: 2025-08-08
• Last Update Submitted: 2025-08-20
• Last Update Posted: 2025-08-27
• Study Start: 2026-01-31
• Primary Completion: 2028-03-31
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 439

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Percentage of participants Smoking cessation rates (Randomized groups only)	Up to 6 months	The rate of smoking cessation will be defined as the percentage of participants who are abstinent from smoking through self-report and biochemical verification using salivary cotinine levels obtained at 6 months after lung cancer screening
Mean number of quit attempts over time (Randomized groups only)	Up to 6 months	The number of self-reported 7-day quit attempts over time since lung cancer screening (LCS) will be recorded. Mean and standard deviation will be reported.
Percentage of participants who reported use of smoking cessation resources (Randomized groups only)	Up to 6 months	Self-reported use of evidence-based smoking cessation resources (enabling factors) after the lung cancer screening (for example, pharmacotherapy for smoking cessation, calling the California Smokers Helpline, group or individual counseling from healthcare providers, etc.) will be reported as a percentage of all participants by arm.

Secondary Outcome Measures

Name	Time	Method
Changes in frequency of response to "Are you seriously thinking of quitting smoking?" over time (Randomized groups only)	Up to 6 months	The participants readiness to quit will be measured using the Stages of Change questionnaire - single item, which asks "Are you seriously thinking of quitting smoking?" Answers range from 'Yes, within the next 30 days', 'Yes, within the next 6 months', and 'No, not thinking of quitting'. Changes in frequency of response over time will be reported.
Changes in scores on the Readiness and Motivation to Quit Smoking Questionnaire (RMQ) over time (Randomized groups only)	Up to 6 months	The RMQ is a 11 item self-report, that is used to assess the degree to which measures a person may be ready or motivated to change smoking habits and behaviors. The questionnaire consists of 3 factors: Change smoking behavior (5 items), Motivation to cut down (4 items), and Confidence (2 items). Questions are responded to as Yes/No, or range from "Not at all" to "Very", or ask the duration of time before quitting smoking. The greater the number of positive responses indicates a greater readiness to quit, a greater motivation to quit, and/or a greater confidence to quit smoking.

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States