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

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ClinicalTrials.gov Identifier: NCT03611881
Recruitment Status : Recruiting
First Posted : August 2, 2018
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Elyse Park, PhD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking, Tobacco Behavioral: Counseling Drug: Nicotine patch Behavioral: Community Resource Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: NRT




Primary Outcome Measures :
  1. Self-reported past 7-day smoking abstinence [ Time Frame: 6 Months after enrollment ]
    Patient self-report of no cigarette smoking in the past 7 days


Secondary Outcome Measures :
  1. Self-reported past 7-day smoking abstinence [ Time Frame: 3 months after enrollment ]
    Patient self-report of no cigarettes smoked in the past 7 days

  2. Proportion of patients with >50% reduction in cigarettes smoked per day [ Time Frame: 3 Months ]
    >50% decrease in cigarettes smoked per day between baseline and follow-up

  3. Proportion of patients with >50% reduction in cigarettes smoked per day [ Time Frame: 6 months ]
    >50% decrease in cigarettes smoked per day between baseline and follow-up

  4. Proportion of patients who make an intentional attempt to quit smoking [ Time Frame: 3 months ]
    Intentional attempt to quit smoking cigarettes that lasts for >=24 hours


Other Outcome Measures:
  1. Biochemically-verified past 7-day abstinence from cigarette smoking [ Time Frame: 6 Months - no longer in use after 7/6/2020 ]
    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.

  2. Biochemically-verified past 7-day abstinence from cigarette smoking [ Time Frame: 3 Months - no longer in use after 7/6/2020 ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03611881


Contacts
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Contact: Elyse R Park, Ph.D. (617) 724-6836 epark@mgh.harvard.edu
Contact: Caylin J Marotta, MPH (617) 724-1861 screenassist@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elyse R Park, PhD         
Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jessica Lorusso         
Brigham & Women's Faulkner Hospital Recruiting
Boston, Massachusetts, United States, 02130
Contact: Jennifer Haas, MD         
Newton-Wellesley Hospital Recruiting
Newton, Massachusetts, United States, 02462
Contact: Anand Prabhakar, MD         
Martha's Vineyard Hospital Recruiting
Oak Bluffs, Massachusetts, United States, 02557
Contact: Pieter Pil, MD, PhD         
Salem Hospital Recruiting
Salem, Massachusetts, United States, 01970
Contact: Amie Samuylov         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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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
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Responsible Party: Elyse Park, PhD, Associate Professor of Psychiatry, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03611881    
Other Study ID Numbers: 2018P000539/PHS
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elyse Park, PhD, Massachusetts General Hospital:
lung screening
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action