Capitalizing on a Teachable Moment to Promote Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Self-Help (SHI); Behavioral: Usual Care (UC)

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: James and Esther King Biomedical Research Program

Publications and helpful links

Helpful Links

• Moffitt Cancer Center Clinical Trials website

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2014
• Primary Completion (Actual): June 21, 2019
• Study Completion (Actual): June 21, 2019

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: lung cancer prevention
• Other Study ID Numbers: MCC-17952; 4KB05 (Other Identifier: James and Esther King Biomedical Research Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No