ACT Lung Health Intervention: Phase Two

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorDana-Farber Cancer Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Hospitalization due to a serious mental illness (e.g., psychotic disorders) during the prior 6 months.

Adults unable to consent.

Adults younger than 50 or older than 80 years

Individuals who are not yet adults (infants, children, teenagers)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group A: ACT Lung Health InterventionExperimental treatment 1 intervention
Group B: Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months post-baseline assessment
2

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.

Time frame
6 months post-baseline assessment

Secondary outcomes

1

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.

Time frame
Baseline and 6 months post-baseline assessment
2

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.

Time frame
Baseline and 6 months post-baseline assessment
3

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.

Time frame
3 months post-baseline assessment
4

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.

Time frame
3 months post-baseline assessment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

University of Massachusetts, Boston

Collaborator