- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03927989
Tobacco Treatment in the Context of Lung Cancer Screening
February 6, 2024 updated by: Medical University of South Carolina
The proposed study will test a medication plus text messaging intervention specifically designed for lung cancer screening patients.
Half of the patients will receive standard of care, and half will receive the treatment intervention.
Study Overview
Status
Completed
Conditions
Detailed Description
Screening for lung cancer at earlier, more treatable stages has the potential to reduce mortality from the U.S.'s most deadly cancer.
Annual lung cancer screening with low-dose computed tomography is now recommended for high risk individuals based on age and smoking history.
This study will evaluate a smoking cessation intervention for lung cancer screening patients.
We will evaluate quit rates after a standard intervention (brief counseling session at time of lung cancer screening) versus a dual nicotine replacement therapy (NRT) and gain-framed text messaging intervention.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alana Rojewski, PhD
- Phone Number: 7407045853
- Email: rojewski@musc.edu
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion:
- 55 years or older
- 30 pack year history of smoking
- current smoker (defined as breath carbon monoxide>6ppm)
- willing to be randomized
- English speaking
Exclusion:
- unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, substance abuse, or dementia
- in the immediate (within 2 weeks) post myocardial infarction period
- serious arrhythmias
- unstable angina pectoris
- hemodynamically or electrically unstable
- currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking NRT or other cessation medications, enrolled in the Quitline, in another drug study).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Arm
Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients
|
Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.
|
Active Comparator: Standard Care
Advice to quit and brief discussion of tobacco use
|
Brief advice to quit smoking prior to lung cancer screening
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
End of Treatment Abstinence Rates
Time Frame: Week 8 (end of treatment)
|
7-day point prevalence abstinence rates
|
Week 8 (end of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
End of Study Abstinence Rates
Time Frame: 3-month follow-up
|
Effect size estimates at End of Study
|
3-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Alana Rojewski, PhD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2019
Primary Completion (Actual)
October 19, 2023
Study Completion (Actual)
February 1, 2024
Study Registration Dates
First Submitted
April 23, 2019
First Submitted That Met QC Criteria
April 23, 2019
First Posted (Actual)
April 25, 2019
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00068951
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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