Capitalizing on a Teachable Moment to Promote Smoking Cessation

Not Applicable

Completed

• Conditions: Smoking Cessation
• Interventions: Behavioral: Self-Help (SHI); Behavioral: Usual Care (UC)

• Registration Number: NCT02276664
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

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

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 Timeline

• Study Start: 2014-10-20
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-24
• Study First Posted: 2014-10-28
• Primary Completion: 2019-06-21
• Study Completion: 2019-06-21
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-12
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Study 2 - Self-Help Intervention (SHI)	Self-Help (SHI)	The SHI arm will receive the intervention developed in Study I.
Study 2 - Usual Care (UC)	Usual Care (UC)	The UC arm will receive the existing Clearing the Air smoking-cessation manual.

Primary Outcome Measures

Name	Time	Method
Study 2 - Rate of Seven-Day Abstinence	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
Study 1 - Completion of Formative Evaluation	Up to 12 months	Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.

Secondary Outcome Measures

Name	Time	Method
Degree of Practicality	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).
Rate of Intervention Demand	Up to 9 months	Demand will be estimated by noting accrual rates into the study.

Trial Locations

Locations (1)

H Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States