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 : August 5, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking, Tobacco | Behavioral: Counseling Drug: Nicotine patch Behavioral: Community Resource | Phase 4 |
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 |

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 |
- 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
- 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
- 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
- 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
- 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
- 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.
- 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.

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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 |
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).
- 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.

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
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 |
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 |
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 |
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: | August 5, 2020 |
Last Verified: | August 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
lung screening |
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 |