ACT Lung Health Intervention: Phase Two

Dana-Farber Cancer Institute

Status: Begins enrollment in 4 months

Conditions: Smoking (Tobacco) Addiction; Smoking, Cigarette; Smoking, Tobacco; Smoking Behaviors; Smoking Cessation

Treatments: Behavioral: ACT Lung Health Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06945120

25-041

5U54CA156732-14 (U.S. NIH Grant/Contract)

5U54CA156734-14 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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128 participants in 2 patient groups

Group A: ACT Lung Health Intervention

Experimental group

Description:

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

Treatment:

Behavioral: ACT Lung Health Intervention

Group B: Standard Care

No Intervention group

Description:

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