Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)
NCT ID: NCT03611881
Last Updated: 2024-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
642 participants
INTERVENTIONAL
2019-04-01
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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Short, Short, Present
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource
Counselor-facilitated referral to a community-based program to address social needs.
Short, Long, Present
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource
Counselor-facilitated referral to a community-based program to address social needs.
Long, Short, Present
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource.
Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource
Counselor-facilitated referral to a community-based program to address social needs.
Long, Long, Present
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource.
Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource
Counselor-facilitated referral to a community-based program to address social needs.
Short, Short, Absent
4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Short, Long, Absent
4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Long, Short, Absent
8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource.
Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Long, Long, Absent
8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource.
Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Interventions
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Counseling
4 or 8 weeks of behavioral counseling support to promote smoking cessation.
Nicotine patch
2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
Community Resource
Counselor-facilitated referral to a community-based program to address social needs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
80 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Elyse Park, PhD
Associate Professor of Psychiatry
Principal Investigators
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Elyse R Park, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Nancy A Rigotti, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Jennifer Haas, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Brigham & Women's Faulkner Hospital
Boston, Massachusetts, United States
Newton-Wellesley Hospital
Newton, Massachusetts, United States
Martha's Vineyard Hospital
Oak Bluffs, Massachusetts, United States
Salem Hospital
Salem, Massachusetts, United States
Countries
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References
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Park ER, Haas JS, Rigotti NA, Neil JM, Marotta CJ, Wint AJ, Gonzalez I, McGovern SE, Chang Y, Levy DE, Flores EJ, Merker VL, Noonan E, Bliss CC. Integrating Tobacco Treatment Into Lung Cancer Screening: The Screen Assist Factorial Randomized Clinical Trial. JAMA Intern Med. 2025 May 1;185(5):531-539. doi: 10.1001/jamainternmed.2024.8399.
Park ER, Neil JM, Noonan E, Howard SE, Gonzalez I, Marotta C, Wint AJ, Levy DE, Chang Y, Rigotti NA, Haas JS. Leveraging the Clinical Timepoints in Lung Cancer Screening to Engage Individuals in Tobacco Treatment. JNCI Cancer Spectr. 2022 Nov 1;6(6):pkac073. doi: 10.1093/jncics/pkac073.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018P000539/PHS
Identifier Type: -
Identifier Source: org_study_id
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