Evaluating the Impact of CONNECT in a Multilingual Population

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • Saliva Sample

    Other intervention

    Undergo saliva collection

  • Interview

    Other intervention

    Attend a focus group

Treatment groups

439 Participants
are divided into 4 treatment groups
Group A: Focus GroupOther 1 intervention
Group B: Beta GroupActive comparator 1 intervention
Group C: Group 1: CONNECT Multi-lingual interventionExperimental treatment 2 interventions
Group D: Group 2: Control GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Up to 6 months
2

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.

Time frame
Up to 6 months
3

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.

Time frame
Up to 6 months

Secondary outcomes

1

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.

Time frame
Up to 6 months
2

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.

Time frame
Up to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

Tobacco Related Disease Research Program

Collaborator