University of California San Francisco
San Francisco, California, 94143, United States
Location contact
Anita Ponce, MSc
CONTACT
Judith Walsh, MD, MPH
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07111936
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.
Trial opening soon.
Get Notified50 year–80 year
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
Anita Ponce, MSc
CONTACT
Judith Walsh, MD, MPH
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: CONNECT Multilingual program
Undergo saliva collection
Other names: Saliva Sample collection
Attend a focus group
Time frame: Up to 6 months
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
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
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
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
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.
Contact information is provided by the study sponsor or research team.
University of California, San Francisco
Other
Evaluating the Impact of CONNECT, a Novel Smoking Cessation Intervention, in a Diverse, Multilingual Population
Acronym: CONNECT-ML
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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