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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Tobacco Treatment in the Context of Lung Cancer Screening

Clinicaltrials.gov identifier NCT03927989

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted May 18, 2020

Study Description

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.

  • Condition or Disease:Smoking Cessation
  • Intervention/Treatment: Behavioral: Text messaging plus nicotine replacement therapy
    Other: Standard Care at Lung Cancer Screening
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 80 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Tobacco Treatment in the Context of Lung Cancer Screening
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: August 2022
Arms and interventions
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
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.
Active Comparator: Standard Care
Advice to quit and brief discussion of tobacco use
Other: Standard Care at Lung Cancer Screening
Brief advice to quit smoking prior to lung cancer screening
Outcome Measures
  • Primary Outcome Measures: 1. End of Treatment Abstinence Rates [ Time Frame: Week 8 (end of treatment) ]
    7-day point prevalence abstinence rates
  • Secondary Outcome Measures: 1. End of Study Abstinence Rates [ Time Frame: 3-month follow-up ]
    Effect size estimates at End of Study
Eligibility Criteria
  • Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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).

Contacts and Locations
Contacts

Contact: Alana Rojewski, PhD 7407045853 rojewski@musc.edu

Locations

United States, South Carolina
Medical University of South Carolina
Charleston

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator: Alana Rojewski, PhD Medical University of South Carolina

More Information
  • Responsible Party: Medical University of South Carolina
  • ClinicalTrials.gov Identifier: NCT03927989 History of Changes
  • Other Study ID Numbers: Pro00068951
  • First Posted: April 25, 2019 Key Record Dates
  • Last Update Posted: May 18, 2020
  • Last Verified: May 2020
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No