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| ID | Type | Description | Link |
|---|---|---|---|
| 4KB05 | Other Identifier | James and Esther King Biomedical Research Program |
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| Name | Class |
|---|---|
| James and Esther King Biomedical Research Program | OTHER |
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The purpose of this study is to develop and test a self-help smoking cessation treatment for patients receiving a lung cancer screening computed tomography (CT) scan.
Conduct Formative Research (Months 1 - 4): Identification of emergent themes and responses to existing booklets.
Adapt and Refine Booklets (Months 5 - 8): Advanced drafts of booklets.
Final Reactions to Draft Booklets (Months 9 - 12): Series of smoking cessation booklets for spiral computed tomography (CT) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 1 - Focus Groups | No Intervention | Using focus group methodology, investigators will identify and explore new content topics for inclusion in smoking cessation booklets and gather feedback about the existing Stop Smoking for Good booklets regarding tone and message design. Results will be used to modify and adapt the existing cessation intervention. | |
| Study 2 - Self-Help Intervention (SHI) | Experimental | The SHI arm will receive the intervention developed in Study I. |
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| Study 2 - Usual Care (UC) | Active Comparator | The UC arm will receive the existing Clearing the Air smoking-cessation manual. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Help (SHI) | Behavioral | The newly revised Stop Smoking for Good booklets. |
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| Measure | Description | Time Frame |
|---|---|---|
| Study 1 - Completion of Formative Evaluation | Complete formative research to adapt and refine the existing Stop Smoking for Good booklets. | Up to 12 months |
| Study 2 - Rate of Seven-Day Abstinence | Up to 9 months | Seven-day abstinence will be assessed at each follow-up, allowing for calculation of point-prevalence abstinence rates. For this pilot, we will not bioverify self-reported abstinence. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Intervention Demand | Demand will be estimated by noting accrual rates into the study. | Up to 9 months |
| Degree of Practicality | Practicality encompasses the degree to which investigators are able to carry out all the piloted elements of the planned randomized control trial (RCT) successfully and efficiently (i.e., recruitment, screening, randomization, and follow-up). |
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Inclusion Criteria:
Study 1
Study 2
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Brandon, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Lee Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D009313 | National Health Programs |
| ID | Term |
|---|---|
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
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| Usual Care (UC) | Behavioral | The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI). |
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| Up to 9 months |