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

NCT02267096 | Completed Phase 3

• 1 other identifier: 2011-541
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 3

Brief 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

Smoking; Lung Cancer

Keywords

lung cancer screening

Outcome Measures

Primary Outcomes (1)

• Smoking Status with biochemical verification

  Self-reported 7-day and 30-day point prevalence abstinence with biochemical verification among those who report having quit smoking.

  Measured at 3 months post-randomization

Secondary Outcomes (3)

• Timeframe of Participants' Intention to Quit Smoking

  Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)

• Quit attempts

  Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)

• Cigarettes per day

  Measured at each assessment: baseline (T0), 1-2 days post-receipt of screening result (T1), one-month post-randomization (T2), and 3 months post randomization (T2)

Study Arms (2)

Telephone Counseling (TC)

EXPERIMENTAL

The TC arm will receive the list of minimal treatment interventions plus 3-6 sessions of stepped-care, proactive, telephone counseling.

Behavioral: Telephone Counseling; Behavioral: Minimal Treatment

Minimal Treatment

ACTIVE COMPARATOR

The minimal treatment intervention includes a list of print, online, national telephone quitline phone number, and in-person cessation resources that is sent to participants.

Behavioral: Minimal Treatment

Interventions

Telephone Counseling BEHAVIORAL

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.

Telephone Counseling (TC)

Minimal Treatment BEHAVIORAL

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.

Minimal Treatment; Telephone Counseling (TC)

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• current smoker
• \> 30-pack years
• English-speaking
• ability to provide meaningful consent
• enrolled to undergo lung cancer screening. -

You may not qualify if:

• history of lung cancer
• current treatment for other cancer -

Sponsors & Collaborators

• Georgetown University: lead
• Prevent Cancer Foundation: collaborator

Study Sites (3)

Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Related Publications (4)

• Taylor KL, Cox LS, Zincke N, Mehta L, McGuire C, Gelmann E. Lung cancer screening as a teachable moment for smoking cessation. Lung Cancer. 2007 Apr;56(1):125-34. doi: 10.1016/j.lungcan.2006.11.015. Epub 2006 Dec 28.

  PMID: 17196298 BACKGROUND

• Barry SA, Tammemagi MC, Penek S, Kassan EC, Dorfman CS, Riley TL, Commin J, Taylor KL. Predictors of adverse smoking outcomes in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. J Natl Cancer Inst. 2012 Nov 7;104(21):1647-59. doi: 10.1093/jnci/djs398. Epub 2012 Oct 26.

  PMID: 23104210 BACKGROUND

• Tammemagi MC, Berg CD, Riley TL, Cunningham CR, Taylor KL. Impact of lung cancer screening results on smoking cessation. J Natl Cancer Inst. 2014 May 28;106(6):dju084. doi: 10.1093/jnci/dju084. Print 2014 Jun.

  PMID: 24872540 BACKGROUND

• Taylor KL, Hagerman CJ, Luta G, Bellini PG, Stanton C, Abrams DB, Kramer JA, Anderson E, Regis S, McKee A, McKee B, Niaura R, Harper H, Ramsaier M. Preliminary evaluation of a telephone-based smoking cessation intervention in the lung cancer screening setting: A randomized clinical trial. Lung Cancer. 2017 Jun;108:242-246. doi: 10.1016/j.lungcan.2017.01.020. Epub 2017 Feb 15.

  PMID: 28216065 DERIVED

MeSH Terms

Conditions

Smoking; Lung Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Oncology

Study Record Dates

• First Submitted: October 7, 2014
• First Posted: October 17, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (3)