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Program on Lung Cancer Screening and Tobacco Cessation

NCT02597491 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2023-04-25

No results posted yet for this study

Summary

In this sequential, multiple assignment, randomized trial (SMART) current smokers who are eligible for lung cancer screening will be identified using the electronic medical record at the University of Minnesota and Minneapolis VA (N=1000). All participants will receive 8 weeks of evidence-based first-line smoking cessation treatment. Participants will be eligible for three potential randomizations during one year of smoking intervention: 1) to timing of identifying early response to treatment at 4 vs. 8 weeks (all participants), 2) to telephone-based tobacco longitudinal care (TLC) vs. TLC plus pharmacist-administered Medication Therapy Management (incomplete responders to first-line treatment, Primary Aim), and 3) to monthly TLC contact vs. quarterly TLC contact (complete responders to first-line treatment, Secondary Aim). The primary outcome will be 6 months of prolonged abstinence measured 18 months after the beginning of treatment.

Conditions

  • Smoking

Interventions

BEHAVIORAL

TLC monthly

Tobacco longitudinal care monthly

BEHAVIORAL

TLC quarterly

Tobacco longitudinal care quarterly

BEHAVIORAL

MTM

Medication management therapy

BEHAVIORAL

4 week assessment

4 week assessment

BEHAVIORAL

8 week assessment

8 week assessment

Sponsors & Collaborators

Principal Investigators

  • Anne Joseph, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
55 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2021-05-01
Completion
2022-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02597491 on ClinicalTrials.gov