NCT03200236

Brief Summary

The purpose of this study is to compare intensive telephone counseling (ITC) plus the nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC) among current smokers undergoing lung cancer screening. Smoking-related outcomes will be examined at three, six and twelve months post-randomization.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,114

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2017

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 3, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

November 2, 2023

Status Verified

March 1, 2023

Enrollment Period

3.7 years

First QC Date

June 19, 2017

Last Update Submit

October 31, 2023

Conditions

Smoking, TobaccoTobacco-Related CarcinomaTobacco UseLung Cancer Screening

Keywords

Lung Cancer ScreeningSmoking CessationTobacco Use

Outcome Measures

Primary Outcomes (3)

  • Smoking cessation rate at 3-months post-randomization

    Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).

    Self-report measured at 3-months post-randomization; biochemical verification measured at 3-months.

  • Smoking cessation rate at 6-months post-randomization

    Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).

    Self-report measured at 6-months post-randomization; biochemical verification measured at 6-months.

  • Smoking cessation rate at 12-months post-randomization

    Comparison between study arms of 7-day and 30-day point prevalence cessation. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).

    Self-report measured at 12-months post-randomization; biochemical verification measured at 12-month assessment;

Secondary Outcomes (6)

  • Readiness to quit

    Measured at baseline (T0), 1-2 days post-receipt of screening result (T1), and 3-months (T2), 6-months (T3), and 12-months post-randomization (T4).

  • Quit attempts

    Baseline (T0), 1-2 days post-receipt of screening result (T1),3-, 6- and 12- months post-randomization (T2, T3, T4)

  • TC intervention fidelity

    Through study completion, an average of 3 months post-randomization.

  • Patient reach and patient engagement

    Through study completion, an average of 3 months post-randomization.

  • Costs per arm for study outcomes

    Through study completion, an average of 3 months post-randomization.

  • +1 more secondary outcomes

Study Arms (2)

Intensive Telephone Counseling

EXPERIMENTAL

This arm provides a multi-faceted, 8-session intensive telephone counseling (ITC) protocol, tailored on lung cancer screening results, with 8-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.

Behavioral: Intensive Telephone Counseling (8 sessions) with nicotine replacement

Usual Care

ACTIVE COMPARATOR

This arm provides a multi-faceted, 3-session usual care telephone counseling (UC) protocol, with 2-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.

Behavioral: Usual Care: Telephone counseling (3 sessions) with nicotine replacement

Interventions

Intensive Telephone Counseling (8 sessions) with nicotine replacementBEHAVIORAL

Participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine replacement patches. A counselor-initiated discussion of screening results will also be included throughout the counseling sessions.

Intensive Telephone Counseling
Usual Care: Telephone counseling (3 sessions) with nicotine replacementBEHAVIORAL

Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches.

Usual Care

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a \>20-pack year smoking history (i.e., smoked at least a pack a day for 20 years)
  • Current smokers, regardless of number smoked per day
  • Can be smoking cigarettes, cigarillos, or little cigars
  • English- or Spanish-speaking
  • Ability to provide meaningful consent
  • Have registered for CT lung cancer screening at one of our five participating lung screening sites (for enrollment) and have completed CT lung cancer screening (for subsequent follow-ups).
  • Current smokers are eligible to participate regardless of prior lung cancer screening or prior cessation treatment. Smokers not yet ready to quit will be encouraged to participate.

You may not qualify if:

  • Previously diagnosed with lung cancer
  • Diagnosed with lung cancer during the study (although still eligible to receive free telephone counseling and nicotine replacement)
  • At the T1 assessment when randomization occurs, individuals who have been quit for 8+ days will not be randomized. We will request that they participate in follow-up assessments of smoking status at 3-, 6- and 12-months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Georgetown University Medical Center

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

Location

Baptist Health South Florida

Miami, Florida, 33176, United States

Location

UnityPoint Health --Trinity Medical Center

Moline, Illinois, 61265, United States

Location

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

MedStar Shah Medical Group

Hollywood, Maryland, 20636, 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 (10)

  • Taylor KL, Deros DE, Fallon S, Stephens J, Kim E, Lobo T, Davis KM, Luta G, Jayasekera J, Meza R, Stanton CA, Niaura RS, Abrams DB, McKee B, Howell J, Ramsaier M, Batlle J, Dornelas E, Parikh V, Anderson E. Study protocol for a telephone-based smoking cessation randomized controlled trial in the lung cancer screening setting: The lung screening, tobacco, and health trial. Contemp Clin Trials. 2019 Jul;82:25-35. doi: 10.1016/j.cct.2019.05.006. Epub 2019 May 23.

    PMID: 31129371BACKGROUND

  • Cadham CJ, Cao P, Jayasekera J, Taylor KL, Levy DT, Jeon J, Elkin EB, Foley KL, Joseph A, Kong CY, Minnix JA, Rigotti NA, Toll BA, Zeliadt SB, Meza R, Mandelblatt J; CISNET-SCALE Collaboration. Cost-Effectiveness of Smoking Cessation Interventions in the Lung Cancer Screening Setting: A Simulation Study. J Natl Cancer Inst. 2021 Aug 2;113(8):1065-1073. doi: 10.1093/jnci/djab002.

    PMID: 33484569BACKGROUND

  • Cadham CJ, Jayasekera JC, Advani SM, Fallon SJ, Stephens JL, Braithwaite D, Jeon J, Cao P, Levy DT, Meza R, Taylor KL, Mandelblatt JS; CISNET-SCALE Collaboration. Smoking cessation interventions for potential use in the lung cancer screening setting: A systematic review and meta-analysis. Lung Cancer. 2019 Sep;135:205-216. doi: 10.1016/j.lungcan.2019.06.024. Epub 2019 Jul 6.

    PMID: 31446996BACKGROUND

  • Taylor KL, Williams RM, Li T, Luta G, Smith L, Davis KM, Stanton CA, Niaura R, Abrams D, Lobo T, Mandelblatt J, Jayasekera J, Meza R, Jeon J, Cao P, Anderson ED; Georgetown Lung Screening, Tobacco, and Health Trial. A Randomized Trial of Telephone-Based Smoking Cessation Treatment in the Lung Cancer Screening Setting. J Natl Cancer Inst. 2022 Oct 6;114(10):1410-1419. doi: 10.1093/jnci/djac127.

    PMID: 35818122RESULT

  • Cao P, Smith L, Mandelblatt JS, Jeon J, Taylor KL, Zhao A, Levy DT, Williams RM, Meza R, Jayasekera J. Cost-Effectiveness of a Telephone-Based Smoking Cessation Randomized Trial in the Lung Cancer Screening Setting. JNCI Cancer Spectr. 2022 Jul 1;6(4):pkac048. doi: 10.1093/jncics/pkac048.

    PMID: 35818125RESULT

  • Williams RM, Eyestone E, Smith L, Philips JG, Whealan J, Webster M, Li T, Luta G, Taylor KL, On Behalf Of The Lung Screening Tobacco Health Trial. Engaging Patients in Smoking Cessation Treatment within the Lung Cancer Screening Setting: Lessons Learned from an NCI SCALE Trial. Curr Oncol. 2022 Mar 23;29(4):2211-2224. doi: 10.3390/curroncol29040180.

    PMID: 35448154RESULT

  • Williams RM, Cordon M, Eyestone E, Smith L, Luta G, McKee BJ, Regis SM, Abrams DB, Niaura RS, Stanton CA, Parikh V, Taylor KL; Lung Screening, Tobacco, Health Trial. Improved motivation and readiness to quit shortly after lung cancer screening: Evidence for a teachable moment. Cancer. 2022 May 15;128(10):1976-1986. doi: 10.1002/cncr.34133. Epub 2022 Feb 10.

    PMID: 35143041RESULT

  • Eyestone E, Williams RM, Luta G, Kim E, Toll BA, Rojewski A, Neil J, Cinciripini PM, Cordon M, Foley K, Haas JS, Joseph AM, Minnix JA, Ostroff JS, Park E, Rigotti N, Sorgen L, Taylor KL. Predictors of Enrollment of Older Smokers in Six Smoking Cessation Trials in the Lung Cancer Screening Setting: The Smoking Cessation at Lung Examination (SCALE) Collaboration. Nicotine Tob Res. 2021 Nov 5;23(12):2037-2046. doi: 10.1093/ntr/ntab110.

    PMID: 34077535RESULT

  • Kim E, Williams RM, Eyestone E, Cordon M, Smith L, Davis K, Luta G, Anderson ED, McKee B, Batlle J, Ramsaier M, Howell J, Parikh V, Geronimo M, Stanton C, Niaura R, Abrams D, Taylor KL; Lung Screening, Tobacco and Health Trial. Predictors of attrition in a smoking cessation trial conducted in the lung cancer screening setting. Contemp Clin Trials. 2021 Jul;106:106429. doi: 10.1016/j.cct.2021.106429. Epub 2021 May 6.

    PMID: 33964415RESULT

  • Cordon M, Eyestone E, Hutchison S, Dunlap D, Smith L, Williams RM, Kim E, Kao JY, Hurtado-de-Mendoza A, Stanton C, Davis K, Frey J, McKee B, Parikh V, Taylor KL; Lung Screening, Tobacco, and Health Study. A qualitative study exploring older smokers' attitudes and motivation toward quitting during the COVID-19 pandemic. Prev Med Rep. 2021 Mar 11;22:101359. doi: 10.1016/j.pmedr.2021.101359. eCollection 2021 Jun.

    PMID: 33868901RESULT

MeSH Terms

Conditions

Tobacco SmokingTobacco UseSmoking Cessation

Condition Hierarchy (Ancestors)

SmokingBehaviorHealth Behavior

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2017

First Posted

June 27, 2017

Study Start

May 3, 2017

Primary Completion

January 30, 2021

Study Completion

January 30, 2022

Last Updated

November 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Deidentified patient data will be shared with the National Cancer Institute as part of the SCALE collaboration.

Locations

US(7)