Efficacy of an Asian Culture-tailored Lung Health (ACT) Intervention on Lung Cancer Screening and Smoking Cessation in Asian Americans
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Group A: ACT Lung Health Intervention
Participants will be randomized 1:1 in blocks, stratified by ethnicity and readiness to quit smoking and will complete:
- Baseline assessment
- Eight telephone or video counseling sessions over 8 weeks
- Nicotine replacement therapy (NRT) patches, gums and lozenges will be provided
- Written educational materials on lung cancer screening will be provided
- Assessments at 1, 3, and 6 months
- 3 month saliva test
- 6 month saliva test
Intervention: ACT Lung Health Intervention (Behavioral)
Group B: Standard Care
Participants will be randomized 1:1 in blocks, stratified by ethnicity and readiness to quit smoking and will complete:
- Baseline assessment
- Six telephone or video counseling sessions over 8 weeks
- Nicotine replacement therapy (NRT) patches, gums and lozenges will be provided
- Written educational materials on lung cancer screening will be provided
- Assessments at 1, 3, and 6 months
- 3 month saliva test
- 6 month saliva test
Outcomes
Primary Outcomes
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
Time Frame: 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)
Time Frame: 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 Outcomes
- Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A)(Baseline and 6 months post-baseline assessment)
- Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A)(Within 6 months post-baseline assessment)
- Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B)(Within 6 months post-baseline assessment)
- Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B)(Baseline and 6 months post-baseline assessment)
- Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A)(3 months post-baseline assessment)
- Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group B)(3 months post-baseline assessment)
- Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)(6 months post-baseline assessment)
- Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)(6 months post-baseline assessment)
Investigators
Mary E. Cooley, Phd
Principal Investigator
Dana-Farber Cancer Institute