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Capitalizing on a Teachable Moment to Promote Smoking Cessation
This study is ongoing, but not recruiting participants.
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
ClinicalTrials.gov Identifier:
NCT02276664
First received: October 21, 2014
Last updated: May 25, 2017
Last verified: May 2017
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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.
| Condition | Intervention |
|---|---|
| Smoking Cessation | Behavioral: Self-Help (SHI) Behavioral: Usual Care (UC) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: No masking Primary Purpose: Prevention |
| Official Title: | Capitalizing on a Teachable Moment to Promote Smoking Cessation |
Resource links provided by NLM:
Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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).
| Enrollment: | 35 |
| Actual Study Start Date: | October 20, 2014 |
| Estimated Study Completion Date: | March 2019 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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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.
|
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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).
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02276664
Please refer to this study by its ClinicalTrials.gov identifier: NCT02276664
Locations
| 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
| Principal Investigator: | Thomas Brandon, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT02276664 History of Changes |
| Other Study ID Numbers: |
MCC-17952 4KB05 ( Other Identifier: James and Esther King Biomedical Research Program ) |
| Study First Received: | October 21, 2014 |
| Last Updated: | May 25, 2017 |
| 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 |
ClinicalTrials.gov processed this record on June 23, 2017