ACT Lung Health Intervention: Phase Two

NCT ID: NCT06945120

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-04

Study Completion Date

2026-12-31

Brief Summary

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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

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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 60 participants are expected to take part in this research study.

The National Cancer Institute is providing funding for this trial.

Conditions

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Smoking Cessation Smoking Behaviors Smoking, Tobacco Smoking, Cigarette Smoking (Tobacco) Addiction

Keywords

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Smoking Cessation Lung Cancer Screening Smoking (Tobacco) Addiction Smoking, Cigarette Smoking, Tobacco Smoking Behaviors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group A: ACT Lung Health Intervention

Participants will be randomized 1:1 by block size and stratified by ethnicity and readiness to quit smoking and will complete:

* Baseline visit
* Questionnaires at 1, 3, and 6 months
* 3 month saliva test
* Weekly Zoom sessions
* 6 month saliva test

Group Type EXPERIMENTAL

ACT Lung Health Intervention

Intervention Type 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.

Group B: Standard Care

Participants will be randomized 1:1 by block size and stratified by ethnicity and readiness to quit smoking and will complete:

* Baseline visit
* Questionnaires at 1, 3, and 6 months
* 3 month saliva test
* Weekly Zoom sessions
* 6 month saliva test

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Asian Culturally Tailored Lung Health (ACT) Intervention

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Massachusetts, Boston

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Mary E. Cooley, Phd

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Cooley, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mary Cooley, PhD

Role: CONTACT

Phone: 617-632-5096

Email: [email protected]

Facility Contacts

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Mary Cooley, PhD

Role: primary

Mary Cooley, PhD

Role: primary

Other Identifiers

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5U54CA156734-14

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5U54CA156732-14

Identifier Type: NIH

Identifier Source: secondary_id

View Link

25-041

Identifier Type: -

Identifier Source: org_study_id