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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-05153 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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| Name | Class |
|---|---|
| Tobacco Related Disease Research Program | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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 |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in frequency of response to "Are you seriously thinking of quitting smoking?" over time (Randomized groups only) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anita Ponce, MSc | Contact | 415-502-1317 | Anita.Ponce@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Judith Walsh, MD, MPH | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94143 | United States |
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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.
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| Saliva Sample | Other | Undergo saliva collection |
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| Interview | Other | Attend a focus group |
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| Up to 6 months |
| Changes in scores on the Readiness and Motivation to Quit Smoking Questionnaire (RMQ) over time (Randomized groups only) | 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. | Up to 6 months |
| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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