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Capitalizing on a Teachable Moment to Promote Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02276664
Recruitment Status : Completed
First Posted : October 28, 2014
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
James and Esther King Biomedical Research Program
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Self-Help (SHI) Behavioral: Usual Care (UC) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Capitalizing on a Teachable Moment to Promote Smoking Cessation
Actual Study Start Date : October 20, 2014
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : June 21, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. Rate of Intervention Demand [ Time Frame: Up to 9 months ]
    Demand will be estimated by noting accrual rates into the study.

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Florida
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
James and Esther King Biomedical Research Program
Investigators
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Principal Investigator: Thomas Brandon, Ph.D. H. Lee Moffitt Cancer Center and Research Institute
More Information
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Additional Information:
Moffitt Cancer Center Clinical Trials website  This link exits the ClinicalTrials.gov site

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02276664    
Other Study ID Numbers: MCC-17952
4KB05 ( Other Identifier: James and Esther King Biomedical Research Program )
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
lung cancer prevention