Low Dose Computed Tomography for Lung Cancer Screening

Not Applicable

Terminated

• Conditions: Smoking
• Interventions: Behavioral: Usual Care; Behavioral: WEB+TXT+TTS; Behavioral: WEB+TXT

• Registration Number: NCT03084835
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-14
• Study First Posted: 2017-03-21
• Study Start: 2017-08-14
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC	Usual Care	Usual Care
WEB+TXT+TTS	WEB+TXT+TTS	Digital plus Counseling Intervention
WEB+TXT	WEB+TXT	Digital Intervention

Primary Outcome Measures

Name	Time	Method
smoking abstinence	12 months	biochemically confirmed 12 month smoking abstinence of UC;

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States