Low Dose Computed Tomography for Lung Cancer Screening (LDCT)

Mayo Clinic

Status: Terminated

Conditions: Smoking

Treatments: Behavioral: WEB+TXT; Behavioral: Usual Care; Behavioral: WEB+TXT+TTS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03084835

1R01CA207048-01 (U.S. NIH Grant/Contract)

16-004891

Details and patient eligibility

About

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 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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

UC

Active Comparator group

Description:

Usual Care

Treatment:

Behavioral: Usual Care

WEB+TXT

Active Comparator group

Description:

Digital Intervention

Treatment:

Behavioral: WEB+TXT

WEB+TXT+TTS

Active Comparator group

Description:

Digital plus Counseling Intervention

Treatment:

Behavioral: WEB+TXT+TTS