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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54CA156734-14 | U.S. NIH Grant/Contract | View source | |
| 5U54CA156732-14 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| University of Massachusetts, Boston | OTHER |
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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.
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 50 participants are expected to take part in this research study.
The National Cancer Institute is providing funding for this trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 6 months post-baseline assessment |
| Change in Number of Cigarettes Smoked per Day from Baseline to 6 Months (Group B) |
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Inclusion Criteria:
Exclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Mary Cooley, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02115 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| D000073865 | Cigarette Smoking |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D003192 | Compulsive Behavior |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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The mean change in the number of cigarettes smoked by participants per day from baseline to 6 months post-baseline. |
| Baseline and 6 months post-baseline assessment |
| 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. | 3 months post-baseline assessment |
| 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. | 3 months post-baseline assessment |
| Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group A) | The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 6-month follow-up. | 6 months post-baseline assessment |
| Self-Reported 7-Day Point Prevalence Smoking Abstinence at 6 Months (Group B) | The proportion of participants who self-report not smoking cigarettes (not even a puff) in the past 7 days at the 6-month follow-up. | 6 months post-baseline assessment |
| Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Group A) | The proportion of participants eligible for lung cancer screening who have completed lung cancer screening using LDCT within 6 months after baseline assessment. Completion will be verified by self-report and/or by obtaining a copy of the LDCT results from participants. | Within 6 months post-baseline assessment |
| Completion of Lung Cancer Screening with Low-Dose Computed Tomography (LDCT) at 6 Months (Arm B) | The proportion of participants eligible for lung cancer screening who have completed lung cancer screening using LDCT within 6 months after baseline assessment. Completion will be verified by self-report and/or by obtaining a copy of the LDCT results from participants. | Within 6 months post-baseline assessment |
| University of Massachusetts-Boston | Recruiting | Boston | Massachusetts | 02125 | United States |
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| D007175 |
| Impulsive Behavior |