ACT Lung Health Intervention for Smoking

Overseen By Mary Cooley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Recent LDCT, Serious mental illness, Lung cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

128 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the ACT Lung Health Intervention treatment for smoking?

The research highlights that airway clearance techniques (ACTs) are important for treating chronic lung diseases, although more evidence is needed. Additionally, smoking cessation, which is a key part of managing lung health, has been shown to improve health status in patients with chronic lung conditions. ^{1 2 3 4 5}

What is the purpose of 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.

Research Team

Mary Cooley, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

The ACT Lung Health Intervention trial is for Chinese and Korean American smokers aged 50-80 with a significant smoking history, who currently smoke and have health insurance, a primary healthcare provider, and can video-call. Excluded are those under 50 or over 80, unable to consent, pregnant women, prisoners, recent serious mental illness hospitalization or previous lung cancer.

Inclusion Criteria

I am between 50-80 years old and have a history of smoking equivalent to 20 pack-years.

Currently have active health insurance coverage and a primary healthcare provider

Self-identify as either Chinese or Korean

Exclusion Criteria

Had LDCT screening done within the last 2 years

I am between 50 and 80 years old, can consent, am not pregnant, and not imprisoned.

I have not been hospitalized for a serious mental illness in the last 6 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants complete baseline visit and initial questionnaires

1 week

1 visit (in-person)

Intervention

Participants receive counseling and educational program for smoking cessation

6 months

Weekly Zoom sessions, questionnaires at 1, 3, and 6 months, saliva tests at 3 and 6 months

Follow-up

Participants are monitored for smoking abstinence and lung cancer screening completion

6 months

Questionnaires and saliva tests

Treatment Details

Interventions

• ACT Lung Health Intervention

Trial Overview This phase two study tests a counseling and educational program aimed at helping high-risk lung cancer candidates among Chinese and Korean American smokers quit smoking to improve their lung health.

Participant Groups

Group I: Group A: ACT Lung Health Intervention Experimental Treatment 1 Intervention

Participants will be randomized 1:1 by block size and stratified by ethnicity, gender, 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 II: Group B: Standard Care Active Control 1 Intervention

Participants will be randomized 1:1 by block size and stratified by ethnicity, gender, 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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Signs of progress in the Australian post-2000 COPD experience, but some old problems remain. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Outcome measures for airway clearance techniques in children with chronic obstructive lung diseases: a systematic review. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Public spirometry for primary prevention of COPD. [2014]

4. France pubmed.ncbi.nlm.nih.gov

[Health status in patients with chronic obstructive pulmonary disease]. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Trends in management and outcomes of COPD patients in primary care, 2000-2009: a retrospective cohort study. [2023]