Evaluating the Impact of CONNECT in a Multilingual Population (CONNECT-ML)

University of California San Francisco (UCSF)

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07111936

NCI-2025-05153 (Registry Identifier)

25635

Details and patient eligibility

About

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.

Full 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.

Enrollment: 439 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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439 participants in 4 patient groups

Focus Group

Other group

Description:

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.

Treatment:

Other: Interview

Beta Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: CONNECT Intervention for multilingual populations

Group 1: CONNECT Multi-lingual intervention

Experimental group

Description:

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

Treatment:

Other: Saliva Sample

Behavioral: CONNECT Intervention for multilingual populations

Group 2: Control Group

Experimental group

Description:

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.

Treatment:

Other: Saliva Sample