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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 : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Elyse Park, PhD, Massachusetts General Hospital

Study Description
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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. Patients who self-report 7-day abstinence at 3- and 6- months follow-up will be asked to provide a saliva sample to assay for cotinine.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 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, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Biochemically-verified past 7-day abstinence from cigarette smoking [ Time Frame: 6 Months ]
    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.


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. 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

  3. 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

  4. 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

  5. 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

  6. Biochemically-verified past 7-day abstinence from cigarette smoking [ Time Frame: 3 Months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 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 Partners 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 55-80 years, 30+ pack/years).

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.
Contacts and Locations
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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: Saif Hawari, MB, BCh, BAO (617) 726-3261 shawari@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elyse R Park, PhD         
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jennifer Haas, MD         
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 Brigham and Women's Hospital
More Information
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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: April 16, 2019
Last Verified: April 2019

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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