Tobacco Treatment in the Context of Lung Cancer Screening

Smoking Cessation Clinical Trial

Official title:

Tobacco Treatment in the Context of Lung Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927989
• Other study ID #: Pro00068951
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2024
• Est. primary completion date: October 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion:

1. 55 years or older

2. 30 pack year history of smoking

3. current smoker (defined as breath carbon monoxide>6ppm)

4. willing to be randomized

5. English speaking

Exclusion:

1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, substance abuse, or dementia

2. in the immediate (within 2 weeks) post myocardial infarction period

3. serious arrhythmias

4. unstable angina pectoris

5. hemodynamically or electrically unstable

6. 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).

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Text messaging plus nicotine replacement therapy
Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.

Other:
• Standard Care at Lung Cancer Screening
Brief advice to quit smoking prior to lung cancer screening

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of Treatment Abstinence Rates	7-day point prevalence abstinence rates	Week 8 (end of treatment)
Secondary	End of Study Abstinence Rates	Effect size estimates at End of Study	3-month follow-up