Capitalizing on a Teachable Moment to Promote Smoking Cessation

• ClinicalTrials.gov Identifier: NCT02276664
• Recruitment Status: Completed
• First Posted: October 28, 2014
• Last Update Posted: August 13, 2020
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborator: James and Esther King Biomedical Research Program
• Information provided by (Responsible Party): H. Lee Moffitt Cancer Center and Research Institute

Tracking Information

• First Submitted Date: October 21, 2014
• First Posted Date: October 28, 2014
• Last Update Posted Date: August 13, 2020
• Actual Study Start Date: October 20, 2014
• Actual Primary Completion Date: June 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 6, 2015)

• 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

Original Primary Outcome Measures (submitted: October 24, 2014)

Number of Focus Group Participants Providing Feedback [ Time Frame: 4 months ]

Goal: 20 - 36 participants will respond to a series of questions to identify their perspectives about benefits and barriers to quitting, perceived risk of continued smoking, and cessation motivations relevant to the teachable moment model generally, and spiral CT, specifically.

Current Secondary Outcome Measures (submitted: April 6, 2015)

• 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).

Original Secondary Outcome Measures (submitted: October 24, 2014)

Number of Participants Who Stopped Smoking - Post Modified Smoking-Cessation Intervention [ Time Frame: 3 months ]

Pilot Test of Smoking-Cessation Intervention Modification. Efficacy data will support a subsequent NCI application for a fully-powered randomized controlled trial.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Capitalizing on a Teachable Moment to Promote Smoking Cessation
• Official Title: Capitalizing on a Teachable Moment to Promote Smoking Cessation
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Smoking Cessation

Intervention

• Behavioral: Self-Help (SHI)
  The newly revised Stop Smoking for Good booklets.
• Behavioral: Usual Care (UC)
  The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).

Study Arms

• 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.
  Intervention: Behavioral: Self-Help (SHI)
• Active Comparator: Study 2 - Usual Care (UC)
  The UC arm will receive the existing Clearing the Air smoking-cessation manual.
  Intervention: Behavioral: Usual Care (UC)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 23, 2016): 35
• Original Estimated Enrollment (submitted: October 24, 2014): 116
• Actual Study Completion Date: June 21, 2019
• Actual Primary Completion Date: June 21, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02276664
• Other Study ID Numbers: MCC-17952; 4KB05 ( Other Identifier: James and Esther King Biomedical Research Program )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
• Study Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: James and Esther King Biomedical Research Program

Investigators

• Principal Investigator: Thomas Brandon, Ph.D.; H. Lee Moffitt Cancer Center and Research Institute

• PRS Account: H. Lee Moffitt Cancer Center and Research Institute
• Verification Date: August 2020