Evaluating the Impact of CONNECT in a Multilingual Population
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CONNECT Intervention for multilingual populations, Saliva Sample, Interview.
- Who it may be relevant to
- Registry conditions: Smoking Cessation, Smoking Cessation Counseling Ability and Practice, Smoking Cessation Counselling, Lung Cancer Screening. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluating the Impact of CONNECT, a Novel Smoking Cessation Intervention, in a Diverse, Multilingual Population
Overview
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.
Interventions
- Behavioral 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. - Other Saliva Sample
Undergo saliva collection - Other Interview
Attend a focus group
Primary outcome measures
- 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]
Secondary outcome measures (2)
- Changes in frequency of response to "Are you seriously thinking of quitting smoking?" over time (Randomized groups only) [Time frame: Up to 6 months]
- Changes in scores on the Readiness and Motivation to Quit Smoking Questionnaire (RMQ) over time (Randomized groups only) [Time frame: Up to 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of California San Francisco — San Francisco
Identifiers
NCT: NCT07111936 · 25635 · NCI-2025-05153