ACT Lung Health Intervention: Phase Two

NCT06945120 | Recruiting

• 3 other identifiers: 25-0415U54CA156734-145U54CA156732-14
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 months post-baseline assessment

Secondary Outcomes (8)

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

  Baseline and 6 months post-baseline assessment

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

  Baseline and 6 months post-baseline assessment

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

  3 months post-baseline assessment

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

  3 months post-baseline assessment

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

  6 months post-baseline assessment

Study Arms (2)

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

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

Interventions

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.

Also known as: Asian Culturally Tailored Lung Health (ACT) Intervention

Group A: ACT Lung Health Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Boston: collaborator
• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

University of Massachusetts-Boston

Boston, Massachusetts, 02125, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation; Smoking; Tobacco Smoking; Cigarette Smoking; Behavior, Addictive

Interventions

Methods

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Tobacco Use; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Mary Cooley, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Cooley, PhD

CONTACT

617-632-5096; mary_cooley@dfci.harvard.edu

Barbara Halpenny, MA, MSW

CONTACT

617-582-7124; barbara_halpenny@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)