ACT Lung Health Intervention: Phase Two

March 11, 2026 updated by: Mary E. Cooley, Phd, Dana-Farber Cancer Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Behavioral: ACT 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.
Other Names:
  • Asian Culturally Tailored Lung Health (ACT) Intervention
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post-baseline assessment
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.
6 months post-baseline assessment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 months post-baseline assessment
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.
Baseline and 6 months post-baseline assessment
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.
3 months post-baseline assessment
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.
3 months post-baseline assessment
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 months post-baseline assessment
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.
6 months post-baseline assessment
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.
Within 6 months post-baseline assessment
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.
Within 6 months post-baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)
University of Massachusetts, Boston

Investigators

  • Principal Investigator: Mary Cooley, PhD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-041
  • 5U54CA156734-14 (U.S. NIH Grant/Contract)
  • 5U54CA156732-14 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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