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Capitalizing on a Teachable Moment to Promote Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02276664
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : August 13, 2020
Sponsor:
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  ICMJE October 21, 2014
First Posted Date  ICMJE October 28, 2014
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE October 20, 2014
Actual Primary Completion Date June 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Capitalizing on a Teachable Moment to Promote Smoking Cessation
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 23, 2016)
35
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2014)
116
Actual Study Completion Date  ICMJE June 21, 2019
Actual Primary Completion Date June 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02276664
Other Study ID Numbers  ICMJE 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  ICMJE Not Provided
Responsible Party H. Lee Moffitt Cancer Center and Research Institute
Study Sponsor  ICMJE H. Lee Moffitt Cancer Center and Research Institute
Collaborators  ICMJE James and Esther King Biomedical Research Program
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP