Capitalizing on a Teachable Moment to Promote Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT02276664|
Recruitment Status : Active, not recruiting
First Posted : October 28, 2014
Last Update Posted : May 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Self-Help (SHI) Behavioral: Usual Care (UC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Capitalizing on a Teachable Moment to Promote Smoking Cessation|
|Actual Study Start Date :||October 20, 2014|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2020|
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).
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|