Smoking CessationNCT06945120
ACT Lung Health Intervention: Phase Two
A study testing ACT Lung Health Intervention in people with Smoking Cessation and Smoking Behaviors, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking Behaviors, Smoking, Tobacco
- What is being tested?
- ACT Lung Health Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Nov 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Mary Cooley, PhD, 617-632-5096, Mary_cooley@dfci.harvard.edu
Barbara Halpenny, MA, MSW, 617-582-7124, barbara_halpenny@dfci.harvard.edu
- Recruiting
University of Massachusetts-Boston
Boston, Massachusetts, 02125
Sun Kim, PhD, RN, sun.kim@umb.edu
Sohyon Pak, MS, sohyon.pak001@umb.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking Cessation, Smoking Behaviors, Smoking, Tobacco, Smoking, Cigarette, Smoking (Tobacco) Addiction
- Being tested
- ACT Lung Health Intervention
- Keywords
- Smoking Cessation, Lung Cancer Screening, Smoking (Tobacco) Addiction, Smoking, Cigarette, Smoking, Tobacco, Smoking Behaviors
- Medical subject headings
- Smoking Cessation, Smoking, Tobacco Smoking, Cigarette Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT Lung Health InterventionBehavioural
Also called Asian Culturally Tailored Lung Health (ACT) 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: ACT Lung Health Intervention | Experimental | 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 Receives: Behavioral: ACT Lung Health Intervention |
| Group B: Standard Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
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.
Measured: 6 months post-baseline assessment
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)
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.
Measured: 6 months post-baseline assessment
Secondary outcomes (8)
Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A)
The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline.
Measured: Baseline and 6 months post-baseline assessment
Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B)
The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline.
Measured: Baseline and 6 months post-baseline assessment
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A)
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.
Measured: 3 months post-baseline assessment
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group B)
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.
Measured: 3 months post-baseline assessment
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
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.
Measured: 6 months post-baseline assessment
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)
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.
Measured: 6 months post-baseline assessment
Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A)
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.
Measured: Within 6 months post-baseline assessment
Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B)
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.
Measured: Within 6 months post-baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start4 Nov 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Massachusetts, Boston
- Responsible party
- Principal investigator, Mary E. Cooley, Phd, Dana-Farber Cancer Institute
- Investigators
- Mary Cooley, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945120
- Sponsor's protocol ID
- 25-041
- Other IDs
- 5U54CA156734-14, 5U54CA156732-14
- Status last verified
- Nov 2025
- First submitted
- 18 Apr 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Asian Culture-tailored Lung Health (ACT) Intervention on Lung Cancer Screening and Smoking Cessation in Asian Americans
- ClinicalTrials.gov ID
- NCT06945120
- Acronym / sponsor ID
- 25-041
- Conditions
- Smoking Cessation, Smoking Behaviors, Smoking, Tobacco, Smoking, Cigarette, Smoking (Tobacco) Addiction
- Keywords
- Smoking Cessation, Lung Cancer Screening, Smoking (Tobacco) Addiction, Smoking, Cigarette, Smoking, Tobacco, Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), University of Massachusetts, Boston
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: ACT Lung Health Intervention | Experimental | Behavioral: ACT Lung Health InterventionParticipants 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 |
| Group B: Standard Care | No intervention | –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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACT Lung Health InterventionAlso: Asian Culturally Tailored Lung Health (ACT) InterventionAn 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. | Behavioural | Group A: ACT Lung Health Intervention |
Primary outcome
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.
8 secondary outcomes
Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A)
Time frame: 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
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A)
Time frame: 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
Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
Time frame: 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
Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary Cooley, PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT Lung Health Intervention in people with Smoking Cessation and Smoking Behaviors, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Cooley, PhD (617-632-5096, mary_cooley@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A) (time frame: 6 months post-baseline assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.