Low Dose Computed Tomography for Lung Cancer Screening

Overview

This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.

Full Title of Study: “Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2019

Detailed Description

Using a 3-arm randomized trial design with repeated measures at 1, 3, 6, and 12 months, the study will randomize N=1650 smokers who present for LDCT lung cancer screening to an passive referral usual care control condition, proactive referral to a digital cessation intervention that combines web and text messaging, or proactive referral to a digital cessation intervention combined with Tobacco Treatment Specialist counseling. The Study will examine overall effectiveness of the interventions in promoting abstinence, the impact of proactive referral to treatment, and the total cost and cost effectiveness of the interventions. The Study will also examine the representativeness of the enrolled sample and explore barriers and facilitators to intervention adoption with LDCT clinic leaders. The trial is structured as a practical clinical trial to answer key questions of direct relevance to LDCT decision-makers.

Interventions

  • Behavioral: Usual Care
    • Brief cessation counseling
  • Behavioral: WEB+TXT
    • Access to Become an Ex website plus text messaging
  • Behavioral: WEB+TXT+TTS
    • Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist

Arms, Groups and Cohorts

  • Active Comparator: UC
    • Usual Care
  • Active Comparator: WEB+TXT
    • Digital Intervention
  • Active Comparator: WEB+TXT+TTS
    • Digital plus Counseling Intervention

Clinical Trial Outcome Measures

Primary Measures

  • smoking abstinence
    • Time Frame: 12 months
    • biochemically confirmed 12 month smoking abstinence of WEB+TXT;
  • smoking abstinence
    • Time Frame: 12 months
    • biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ;
  • smoking abstinence
    • Time Frame: 12 months
    • biochemically confirmed 12 month smoking abstinence of UC;

Participating in This Clinical Trial

Inclusion Criteria

1. Scheduled for LDCT screening 2. Current smoking (every day/some days) 3. At least weekly use of the Internet 4. Current ownership of cell phone with a text messaging plan 5. Willing to receive study text messages. 6. Ability to complete all aspects of the study 7. Ability to provide signed informed consent Exclusion Criteria:

1. Current (in the past 30 days) use of tobacco cessation medication or participation in tobacco cessation treatment. 2. Those with a condition deemed by the investigators to be exclusionary to the study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mayo Clinic
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ivana Croghan, Professor of Medicine – Mayo Clinic
  • Overall Official(s)
    • James T Hays, MD, Principal Investigator, Mayo Clinic
    • David E Midthun, MD, Principal Investigator, Mayo Clinic

References

Graham AL, Burke MV, Jacobs MA, Cha S, Croghan IT, Schroeder DR, Moriarty JP, Borah BJ, Rasmussen DF, Brookover MJ, Suesse DB, Midthun DE, Hays JT. An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial. Trials. 2017 Nov 28;18(1):568. doi: 10.1186/s13063-017-2312-x.

Burke, MV; Graham, AL; Midthun, DE; Hays, JT; Efficacia delle nuove tecnologie digitali di rete per la smoking cessation nello screening del tumore polmonare (Effectiveness of new digital technologies for smoking cessation in lung cancer screening). Tabaccologia 2019; 2:21-25

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