Viewing Study NCT03084835


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Study NCT ID: NCT03084835
Status: TERMINATED
Last Update Posted: 2019-08-29
First Post: 2017-03-09
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Low Dose Computed Tomography for Lung Cancer Screening
Sponsor: Mayo Clinic
Organization:

Study Overview

Official Title: Smoking Cessation in Lung Cancer Screening: Integrated Digital/Clinical Approach
Status: TERMINATED
Status Verified Date: 2019-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Low Study Accrual
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LDCT
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
1R01CA207048-01 NIH None https://reporter.nih.gov/quic… View