Expired Study
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Tampa, Florida 33612


Purpose:

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 summary:

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.


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


Study is Available At:


Original ID:

MCC-17952


NCT ID:

NCT02276664


Secondary ID:

4KB05


Study Acronym:


Brief Title:

Capitalizing on a Teachable Moment to Promote Smoking Cessation


Official Title:

Capitalizing on a Teachable Moment to Promote Smoking Cessation


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

H. Lee Moffitt Cancer Center and Research Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

35


Enrollment Type:

Actual


Overall Contact Information

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

Study Dates

Start Date:October 20, 2014
Completion Date:June 21, 2019
Completion Type:Actual
Primary Completion Date:June 21, 2019
Primary Completion Type:Actual
Verification Date:September 2019
Last Changed Date:September 5, 2019
First Received Date:October 21, 2014

Study Outcomes

Outcome Type:Primary Outcome
Measure:Study 1 - Completion of Formative Evaluation
Time Frame:Up to 12 months
Safety Issues:False
Description:Complete formative research to adapt and refine the existing Stop Smoking for Good booklets.
Outcome Type:Primary Outcome
Measure:Study 2 - Rate of Seven-Day Abstinence
Time Frame:Seven-day abstinence will be assessed at each follow-up, allowing for calculation of point-prevalenc
Safety Issues:False
Description:Up to 9 months
Outcome Type:Secondary Outcome
Measure:Rate of Intervention Demand
Time Frame:Up to 9 months
Safety Issues:False
Description:Demand will be estimated by noting accrual rates into the study.
Outcome Type:Secondary Outcome
Measure:Degree of Practicality
Time Frame:Up to 9 months
Safety Issues:False
Description: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).

Study Interventions

Intervention Type:Behavioral
Name:Self-Help (SHI)
Description:The newly revised Stop Smoking for Good booklets.
Arm Name:Study 2 - Self-Help Intervention (SHI)
Intervention Type:Behavioral
Name:Usual Care (UC)
Description:The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).
Arm Name:Study 2 - Usual Care (UC)

Study Arms

Study Arm Type:No Intervention
Arm Name:Study 1 - Focus Groups
Description: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.
Study Arm Type:Experimental
Arm Name:Study 2 - Self-Help Intervention (SHI)
Description:The SHI arm will receive the intervention developed in Study I.
Study Arm Type:Active Comparator
Arm Name:Study 2 - Usual Care (UC)
Description:The UC arm will receive the existing Clearing the Air smoking-cessation manual.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:H. Lee Moffitt Cancer Center and Research Institute
Agency Class:Other
Agency Type:Collaborator
Agency Name:James and Esther King Biomedical Research Program

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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