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Lombardi Comprehensive Cancer Center/Legacy Pilot Study to Reduce Adverse Smoking Outcomes in the Context of Lung Cancer Screening

NCT02267096 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2016-10-19

No results posted yet for this study

Summary

In 2011, the National Lung Screening Trial (NLST) reported that lung cancer mortality was reduced by 20% with spiral computed tomography (CT) compared to chest X-ray. It is estimated that 8 million people in the US are at high risk for lung cancer and that lung screening could prevent 12,000 deaths annually. Cost effectiveness models suggest that concurrent smoking cessation programs will be essential in order to realize the full benefit of screening. However, there are no clinical guidelines or evidence-based cessation protocols with demonstrated effectiveness in this setting. The investigators are addressing this gap by rigorously testing whether two scalable and pragmatic interventions can significantly boost intention to quit and cessation rates.

Conditions

Interventions

BEHAVIORAL

Telephone Counseling

The TC arm includes a stepped care approach, 3-6 phone sessions, depending on each participant's needs. Within 1-2 days post-T1 assessment, the intervention will begin. Sessions 1-3 (15 min each) will occur approximately weekly over 3-4 weeks, scheduled at participants' convenience and at strategic therapeutic times (e.g., shortly pre/post-quit date). Continuing smokers or newly quit former smokers who would benefit from relapse prevention sessions will receive up to 3 additional sessions, to be completed within 3-4 weeks. The provision of 3-6 sessions is more intensive than several other telephone counseling interventions. A dose response relationship between quitting and number of sessions has been shown in non-volunteer smokers, and based on our pilot data, the investigators expect that a more intensive intervention will be needed for some participants.

BEHAVIORAL

Minimal Treatment

A list of self-help materials (print-, web-, phone-based), the national telephone quitline phone number, and local in person cessation resources will be given to all participants.

Sponsors & Collaborators

  • Prevent Cancer Foundation

    collaborator OTHER

  • Georgetown University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-06-30
Completion
2016-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT02267096 on ClinicalTrials.gov