ACT Lung Health Intervention: Phase Two
- Conditions
- Smoking CessationSmoking BehaviorsSmoking, TobaccoSmoking, CigaretteSmoking (Tobacco) Addiction
- Registration Number
- NCT06945120
- Lead Sponsor
- Dana-Farber Cancer Institute
- 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 128 participants are expected to take part in this research study.
The National Cancer Institute is providing funding for this trial.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 128
- Self-identify as either Chinese or Korean
- Speak either Korean, Mandarin, or English
- Eligible for LDCT screening (50-80 years of age and 20- pack-year smoking history)
- Currently smoking (i.e., having smoked within the prior 30 days),
- Currently have active health insurance coverage and a primary healthcare provider and
- Have access to a video-call device with internet or wireless connection.
- Eastern Cooperative Oncology Group functional status <2
- Live in the United States for the next 12 months
-
Had LDCT screening done within the last 2 years.
-
Hospitalization due to a serious mental illness (e.g., psychotic disorders) during the prior 6 months.
-
Previous history of lung cancer.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
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 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 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.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States