Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS) (ScreenASSIST)

Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening

This randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the delivery of low-dose CT (LDCT) lung cancer screening. Using a factorial design, current smokers who enroll will be randomly assigned to receive these interventions: (1) smoking cessation counseling support by telephone or videoconferencing (short duration vs. long duration); (2) nicotine patch treatment (NRT) (short vs.long duration); (3) counselor-facilitated referral (vs. no referral) to an online resource to connect smokers to a community-based social service resources.

Study Overview

• Status: Completed
• Conditions: Smoking, Tobacco
• Intervention / Treatment: Behavioral: Counseling; Drug: Nicotine patch; Behavioral: Community Resource

Detailed Description

Evidence-based tobacco dependence treatment consists of behavioral counseling and pharmacotherapy. Nicotine patch is an FDA-approved cessation aid. The optimal duration of counseling and pharmacotherapy for patients undergoing low-dose CT (LDCT) lung screening is not clear. In addition, helping smokers to address other social and psychological barriers might help them succeed in quitting smoking. This randomized controlled trial will test, in a factorial design, two options for delivering each of 3 interventions to help current smokers stop smoking in the context of having routine CT lung cancer screening. Patients will receive 4 or 8 weeks of behavioral counseling (with their choice of video conferencing or regular telephone calls), 2 or 8 weeks of nicotine patch, and will receive referral (vs. no referral) to an online resource to connect smokers to community-based social service resources. Outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months.

• Study Type: Interventional
• Enrollment (Actual): 642
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Boston, Massachusetts, United States, 02130
      • Brigham & Women's Faulkner Hospital
    • Newton, Massachusetts, United States, 02462
      • Newton-Wellesley Hospital
    • Oak Bluffs, Massachusetts, United States, 02557
      • Martha's Vineyard Hospital
    • Salem, Massachusetts, United States, 01970
      • Salem Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Scheduled to undergo LDCT-LCS at a participating Mass General Brigham Health Care System LCS site
• Speak English or Spanish.
• Current smokers: smoked a cigarette, even a puff, in the last 30 days.
• Medicare coverage requirement (age 50-80 years, 20+ pack/years).
• Residing within the USA.

Exclusion Criteria:

• Undergoing lung CT as part of a diagnostic or abnormal follow-up evaluation.
• Unable to give informed consent due to psychiatric or cognitive impairment as determined in consultation with study PI or treating clinician.
• No access to a telephone or cannot communicate by telephone.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short, Short, Present; 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.	Behavioral: Counseling; 4 or 8 weeks of behavioral counseling support to promote smoking cessation.; Drug: Nicotine patch; 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.; Other Names: NRT; Behavioral: Community Resource; Counselor-facilitated referral to a community-based program to address social needs.
Experimental: Short, Long, Present; 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.	Behavioral: Counseling; 4 or 8 weeks of behavioral counseling support to promote smoking cessation.; Drug: Nicotine patch; 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.; Other Names: NRT; Behavioral: Community Resource; Counselor-facilitated referral to a community-based program to address social needs.
Experimental: Long, Short, Present; 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.	Behavioral: Counseling; 4 or 8 weeks of behavioral counseling support to promote smoking cessation.; Drug: Nicotine patch; 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.; Other Names: NRT; Behavioral: Community Resource; Counselor-facilitated referral to a community-based program to address social needs.
Experimental: Long, Long, Present; 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.	Behavioral: Counseling; 4 or 8 weeks of behavioral counseling support to promote smoking cessation.; Drug: Nicotine patch; 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.; Other Names: NRT; Behavioral: Community Resource; Counselor-facilitated referral to a community-based program to address social needs.
Experimental: Short, Short, Absent; 4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.	Behavioral: Counseling; 4 or 8 weeks of behavioral counseling support to promote smoking cessation.; Drug: Nicotine patch; 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.; Other Names: NRT
Experimental: Short, Long, Absent; 4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.	Behavioral: Counseling; 4 or 8 weeks of behavioral counseling support to promote smoking cessation.; Drug: Nicotine patch; 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.; Other Names: NRT
Experimental: Long, Short, Absent; 8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.	Behavioral: Counseling; 4 or 8 weeks of behavioral counseling support to promote smoking cessation.; Drug: Nicotine patch; 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.; Other Names: NRT
Experimental: Long, Long, Absent; 8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.	Behavioral: Counseling; 4 or 8 weeks of behavioral counseling support to promote smoking cessation.; Drug: Nicotine patch; 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.; Other Names: NRT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported past 7-day smoking abstinence	Patient self-report of no cigarette smoking in the past 7 days	6 Months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported past 7-day smoking abstinence	Patient self-report of no cigarettes smoked in the past 7 days	3 months after enrollment
Proportion of patients with >50% reduction in cigarettes smoked per day	>50% decrease in cigarettes smoked per day between baseline and follow-up	3 Months
Proportion of patients with >50% reduction in cigarettes smoked per day	>50% decrease in cigarettes smoked per day between baseline and follow-up	6 months
Proportion of patients who make an intentional attempt to quit smoking	Intentional attempt to quit smoking cigarettes that lasts for >=24 hours	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-verified past 7-day abstinence from cigarette smoking	Patient report of no cigarettes smoked in the past 7 days (point prevalence abstinence), confirmed biochemically by saliva cotinine <=10 ng/ml or expired air carbon monoxide (CO) <10 ppm.	6 Months - no longer in use after 7/6/2020
Biochemically-verified past 7-day abstinence from cigarette smoking	Patient report of no cigarettes smoked in the past 7 days (point prevalence abstinence), confirmed biochemically by saliva cotinine <=10 ng/ml or expired air carbon monoxide (CO) <10 ppm.	3 Months - no longer in use after 7/6/2020

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Elyse R Park, PhD, Massachusetts General Hospital; Principal Investigator: Nancy A Rigotti, MD, Massachusetts General Hospital; Principal Investigator: Jennifer Haas, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Estimated): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lung screening
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2018P000539/PHS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No