Capitalizing on a Teachable Moment to Promote Smoking Cessation
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Capitalizing on a Teachable Moment to Promote Smoking Cessation|
- Study 1 - Completion of Formative Evaluation [ Time Frame: Up to 12 months ]Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.
- Study 2 - Rate of Seven-Day Abstinence [ Time Frame: 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. ]Up to 9 months
- Rate of Intervention Demand [ Time Frame: Up to 9 months ]Demand will be estimated by noting accrual rates into the study.
- Degree of Practicality [ Time Frame: Up to 9 months ]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).
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
No Intervention: Study 1 - Focus Groups
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)
The SHI arm will receive the intervention developed in Study I.
Behavioral: Self-Help (SHI)
The newly revised Stop Smoking for Good booklets.
Active Comparator: Study 2 - Usual Care (UC)
The UC arm will receive the existing Clearing the Air smoking-cessation manual.
Behavioral: Usual Care (UC)
The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02276664
|United States, Florida|
|H Lee Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Thomas Brandon, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|