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NCT Number: NCT06945120

ACT Lung Health Intervention: Phase Two

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.

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Key information

Conditions

Smoking Cessation Behavior Behavior, Addictive Cigarette Smoking Compulsive Behavior Health Behavior Impulsive Behavior Smoking Smoking (Tobacco) Addiction Smoking Behaviors Smoking, Cigarette Smoking, Tobacco Tobacco Smoking Tobacco Use

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACT Lung Health Intervention

Behavioral

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.

Other names: Asian Culturally Tailored Lung Health (ACT) Intervention

Primary outcomes

  1. 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.

  2. 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

  1. Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A)

    Time frame: 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.

  2. Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B)

    Time frame: 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.

  3. Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A)

    Time frame: 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.

  4. Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group B)

    Time frame: 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.

  5. Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)

    Time frame: 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.

  6. Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)

    Time frame: 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.

  7. Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A)

    Time frame: 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.

  8. Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Halpenny, MA, MSW

CONTACT

[email protected]

617-582-7124

Mary Cooley, PhD

CONTACT

[email protected]

617-632-5096

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of Massachusetts, Boston

Registry information

Official study title

Efficacy of an Asian Culture-tailored Lung Health (ACT) Intervention on Lung Cancer Screening and Smoking Cessation in Asian Americans

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
Mar 13, 2026

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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