Evaluating the Impact of CONNECT in a Multilingual Population
NCT ID: NCT07111936
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
439 participants
INTERVENTIONAL
2026-01-31
2028-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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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.
Interview
Attend a focus group
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.
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.
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
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
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.
Saliva Sample
Undergo saliva collection
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
80 Years
ALL
Yes
Sponsors
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Tobacco Related Disease Research Program
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Judith Walsh, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2025-05153
Identifier Type: REGISTRY
Identifier Source: secondary_id
25635
Identifier Type: -
Identifier Source: org_study_id
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