Clinical trial NCT03084835: Low Dose Computed Tomography for Lung Cancer Screening
Official title: Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Smoking
Keywords: tobacco
smoking
low dose computed tomography
lung screening
text messaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Truth Initiative
First posted: 2017-03-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: smoking abstinence
timeFrame: 12 months
measure: smoking abstinence
timeFrame: 12 months
measure: smoking abstinence
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James T Hays, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: David E Midthun, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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