Smoking Behaviors, Smoking Cessation, Smoking, Cigarette, Smoking, Tobacco, Smoking (Tobacco) Addiction
Conditions
Keywords
Smoking Cessation, Lung Cancer Screening, Smoking (Tobacco) Addiction, Smoking, Cigarette, Smoking, Tobacco, Smoking Behaviors
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALACT Lung Health Intervention
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.
Sponsors
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
University of Massachusetts, Boston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Self-identify as either Chinese or Korean * Speak either Korean, Mandarin, or English * Are 18 years of age or older * Are current smokers (i.e., have smoked at least 100 traditional cigarettes ever and have smoked at least one traditional cigarette within the prior 30 days) * Will live in the United States for the next 12 months
Exclusion criteria
* Hospitalization due to a serious mental illness (e.g., psychotic disorders) during the prior 6 months. * We will not include any of the following special populations: * Adults unable to consent. * Adults younger than 50 or older than 80 years * Individuals who are not yet adults (infants, children, teenagers) * Pregnant women * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A) | 6 months post-baseline assessment | 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. |
| Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B) | 6 months post-baseline assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A) | Baseline and 6 months post-baseline assessment | The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline. |
| Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B) | Baseline and 6 months post-baseline assessment | The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline. |
| Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A) | 3 months post-baseline assessment | 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. |
| Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group B) | 3 months post-baseline assessment | 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. |
| Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A) | 6 months post-baseline assessment | 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. |
| Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B) | 6 months post-baseline assessment | 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. |
| Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A) | Within 6 months post-baseline assessment | 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. |
| Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B) | Within 6 months post-baseline assessment | 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. |
Countries
United States
Contacts
CONTACTMary Cooley, PhD
CONTACTBarbara Halpenny, MA, MSW
PRINCIPAL_INVESTIGATORMary Cooley, PhD
Dana-Farber Cancer Institute
Outcome results
None listed