Clinical trial NCT06945120: ACT Lung Health Intervention: Phase Two
Official title: Efficacy of an Asian Culture-tailored Lung Health (ACT) Intervention on Lung Cancer Screening and Smoking Cessation in Asian Americans
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-04-25
Enrollment: 128
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
timeFrame: 6 months post-baseline assessment
measure: Biochemically Verified 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)
timeFrame: 6 months post-baseline assessment
measure: Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A)
timeFrame: Within 6 months post-baseline assessment
measure: Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B)
timeFrame: Within 6 months post-baseline assessment
Secondary outcomes:
measure: Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group A)
timeFrame: Baseline and 6 months post-baseline assessment
measure: Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B)
timeFrame: Baseline and 6 months post-baseline assessment
measure: Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group A)
timeFrame: 3 months post-baseline assessment
measure: Self-Reported 7-Day Point Prevalence Smoking Abstinence at 3 Months (Group B)
timeFrame: 3 months post-baseline assessment
measure: Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A)
timeFrame: 6 months post-baseline assessment
measure: Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B)
timeFrame: 6 months post-baseline assessment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary Cooley, PhD
role: PRINCIPAL_INVESTIGATOR
References: