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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02276664
Other study ID # MCC-17952
Secondary ID 4KB05
Status Completed
Phase N/A
First received
Last updated
Start date October 20, 2014
Est. completion date June 21, 2019

Study information

Verified date August 2020
Source H. Lee Moffitt Cancer Center and Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date June 21, 2019
Est. primary completion date June 21, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States H Lee Moffitt Cancer Center Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute James and Esther King Biomedical Research Program

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Study 1 - Completion of Formative Evaluation Complete formative research to adapt and refine the existing Stop Smoking for Good booklets. Up to 12 months
Primary 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 Rate of Intervention Demand Demand will be estimated by noting accrual rates into the study. Up to 9 months
Secondary 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
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