Evaluating the Impact of CONNECT in a Multilingual Population

NCT07111936 | Not Yet Recruiting

• 2 other identifiers: 25635NCI-2025-05153
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 1

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

Keywords

Multilingual

Outcome Measures

Primary Outcomes (3)

• Percentage of participants Smoking cessation rates (Randomized groups only)

  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

  Up to 6 months

• Mean number of quit attempts over time (Randomized groups only)

  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.

  Up to 6 months

• Percentage of participants who reported use of smoking cessation resources (Randomized groups only)

  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.

  Up to 6 months

Secondary Outcomes (2)

• Changes in frequency of response to "Are you seriously thinking of quitting smoking?" over time (Randomized groups only)

  Up to 6 months

• Changes in scores on the Readiness and Motivation to Quit Smoking Questionnaire (RMQ) over time (Randomized groups only)

  Up to 6 months

Study Arms (4)

Focus Group

OTHER

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.

Other: Interview

Beta Group

ACTIVE COMPARATOR

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.

Behavioral: CONNECT Intervention for multilingual populations

Group 1: CONNECT Multi-lingual intervention

EXPERIMENTAL

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

Behavioral: CONNECT Intervention for multilingual populations; Other: Saliva Sample

Group 2: Control Group

EXPERIMENTAL

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.

Other: Saliva Sample

Interventions

CONNECT Intervention for multilingual populations BEHAVIORAL

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.

Also known as: CONNECT Multilingual program

Beta Group; Group 1: CONNECT Multi-lingual intervention

Saliva Sample OTHER

Undergo saliva collection

Also known as: Saliva Sample collection

Group 1: CONNECT Multi-lingual intervention; Group 2: Control Group

Interview OTHER

Attend a focus group

Focus Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Tobacco Related Disease Research Program: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Judith Walsh, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Ponce, MSc

CONTACT

415-502-1317; Anita.Ponce@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be enrolled in the focus group. Once completed, new participants will be enrolled in the beta group. After interim analysis has been completed, new participants will be enrolled in the randomized arms.

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: January 31, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)