Capitalizing on a Teachable Moment to Promote Smoking Cessation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Capitalizing on a Teachable Moment to Promote Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Self-Help (SHI)
* Behavioral: Usual Care (UC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Study 1 Participants for Study I will be drawn from a list of patients who have received a CT scan at the Moffitt Cancer Center Smoked at least one cigarette per week prior to undergoing the CT scan Able to speak and read English Study 2 Smoked at least one cigarette over the past week Able to read English

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Study 1 - Focus Groups<br>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. | |
| Experimental: Study 2 - Self-Help Intervention (SHI)<br>The SHI arm will receive the intervention developed in Study I. | Behavioral: Self-Help (SHI)<br>* The newly revised Stop Smoking for Good booklets.<br>|
| Active Comparator: Study 2 - Usual Care (UC)<br>The UC arm will receive the existing Clearing the Air smoking-cessation manual. | Behavioral: Usual Care (UC)<br>* The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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). | Up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer prevention