Tobacco Treatment in the Context of Lung Cancer Screening

NCT ID: NCT03927989

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-15
• Study Completion Date: 2024-02-01

Brief 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.

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Text messaging plus nicotine replacement therapy

Intervention Type: BEHAVIORAL

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

Standard Care

Advice to quit and brief discussion of tobacco use

Group Type: ACTIVE_COMPARATOR

Standard Care at Lung Cancer Screening

Intervention Type: OTHER

Brief advice to quit smoking prior to lung cancer screening

Interventions

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.

Intervention Type: BEHAVIORAL

Standard Care at Lung Cancer Screening

Brief advice to quit smoking prior to lung cancer screening

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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).

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alana Rojewski, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00068951

Identifier Type: -

Identifier Source: org_study_id