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出境医 / 临床实验 / Tobacco Treatment in the Context of Lung Cancer Screening

Tobacco Treatment in the Context of Lung Cancer Screening

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 Intervention/treatment Phase
Smoking Cessation Behavioral: Text messaging plus nicotine replacement therapy Other: Standard Care at Lung Cancer Screening Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 15, 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
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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
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Contact: Alana Rojewski, PhD 7407045853 rojewski@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Alana Rojewski, PhD    843-876-1593    rojewski@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Alana Rojewski, PhD Medical University of South Carolina
Tracking Information
First Submitted Date  ICMJE April 23, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date May 21, 2021
Actual Study Start Date  ICMJE April 15, 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		End of Treatment Abstinence Rates [ Time Frame: Week 8 (end of treatment) ]
7-day point prevalence abstinence rates
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019) 		End of Study Abstinence Rates [ Time Frame: 3-month follow-up ]
Effect size estimates at End of Study
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tobacco Treatment in the Context of Lung Cancer Screening
Official Title  ICMJE Tobacco Treatment in the Context of Lung Cancer Screening
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Smoking Cessation
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Text messaging plus nicotine replacement therapy
  • Active Comparator: Standard Care
    Advice to quit and brief discussion of tobacco use
    Intervention: Other: Standard Care at Lung Cancer Screening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019) 		80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alana Rojewski, PhD 7407045853 rojewski@musc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03927989
Other Study ID Numbers  ICMJE Pro00068951
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alana Rojewski, PhD Medical University of South Carolina
PRS Account Medical University of South Carolina
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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