This study aims to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer.
This two-arm stratified randomized clinical trial is to test a counseling and educational program designed to improve lung health through smoking cessation for Chinese and Korean American smokers at high risk for lung cancer. Participants will be randomized into one of two groups: Group A: ACT Lung Health Intervention versus Group B: Standard Care. Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, questionnaires, and saliva tests. It is expected participation in this study will last about 6 months. About 50 participants are expected to take part in this research study. The National Cancer Institute is providing funding for this trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
50
An Asian culture-tailored lung health intervention, which includes individual counseling sessions, family coaching, provision of nicotine replacement therapy (NRT) in the form of patches, lozenges, or chewing gum, and educational materials about low-dose computed tomography (LDCT) for lung cancer screening. The eight weekly, counseling sessions with study staff will be conducted via phone call or the Zoom web-conferencing platform.
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGUniversity of Massachusetts-Boston
Boston, Massachusetts, United States
RECRUITINGBiochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
The proportion of participants who have not smoked cigarettes (not even a puff) in the past 7 days at the 6-month follow-up, verified biochemically using salivary cotinine testing. Participants reporting abstinence and not using nicotine replacement therapy (NRT) will perform a salivary cotinine test observed via video call. Cotinine levels ≤3 ng/mL will confirm abstinence.
Time frame: 6 months post-baseline assessment
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)
The proportion of participants who have not smoked cigarettes (not even a puff) in the past 7 days at the 6-month follow-up, verified biochemically using salivary cotinine testing. Participants reporting abstinence and not using nicotine replacement therapy (NRT) will perform a salivary cotinine test observed via video call. Cotinine levels ≤3 ng/mL will confirm abstinence.
Time frame: 6 months post-baseline assessment
Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A)
The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline.
Time frame: Baseline and 6 months post-baseline assessment
Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B)
The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline.
Time frame: Baseline and 6 months post-baseline assessment
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A)
The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 3-month follow-up.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3 months post-baseline assessment
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group B)
The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 3-month follow-up.
Time frame: 3 months post-baseline assessment
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 6-month follow-up.
Time frame: 6 months post-baseline assessment
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)
The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 6-month follow-up.
Time frame: 6 months post-baseline assessment
Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A)
The proportion of participants eligible for lung cancer screening who have completed lung cancer screening using LDCT within 6 months after baseline assessment. Completion will be verified by self-report and/or by obtaining a copy of the LDCT results from participants.
Time frame: Within 6 months post-baseline assessment
Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B)
The proportion of participants eligible for lung cancer screening who have completed lung cancer screening using LDCT within 6 months after baseline assessment. Completion will be verified by self-report and/or by obtaining a copy of the LDCT results from participants.
Time frame: Within 6 months post-baseline assessment