Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2500 participants
INTERVENTIONAL
2011-02-28
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PRO+NRT+TC
Proactive outreach (mailed invitation letter followed by telephone outreach) combined with free nicotine replacement therapy (NRT) and telephone counseling (PRO+NRT+TC)to usual care (UC)
proactive outreach (PRO)
a mailed invitation letter followed by telephone outreach
telephone counseling (TC)
free telephone counseling
Nicotine replacement therapy (NRT)
free nicotine replacement therapy (NRT)
Usual Care (UC)
Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray
Usual care (UC)
nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)
Interventions
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proactive outreach (PRO)
a mailed invitation letter followed by telephone outreach
telephone counseling (TC)
free telephone counseling
Nicotine replacement therapy (NRT)
free nicotine replacement therapy (NRT)
Usual care (UC)
nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)
Eligibility Criteria
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Inclusion Criteria
* Current self-reported cigarette smoker
* Has a valid home address
* An adequate proficiency in English to complete study surveys and participate in telephone counseling.
Exclusion Criteria
18 Years
64 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Steven Fu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Veterans Administration Hospital
Anne Joseph, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Steven Fu, M.D.
Minneapolis, Minnesota, United States
Countries
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References
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Hammett PJ, Japuntich SJ, Sherman SE, Rogers ES, Danan ER, Noorbaloochi S, El-Shahawy O, Burgess DJ, Fu SS. Proactive tobacco treatment for veterans with posttraumatic stress disorder. Psychol Trauma. 2021 Jan;13(1):114-122. doi: 10.1037/tra0000613. Epub 2020 Jul 2.
Hammett PJ, Lando HA, Erickson DJ, Widome R, Taylor BC, Nelson D, Japuntich SJ, Fu SS. Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness. J Behav Med. 2020 Jun;43(3):493-502. doi: 10.1007/s10865-019-00083-8. Epub 2019 Jul 30.
Fu SS, van Ryn M, Nelson D, Burgess DJ, Thomas JL, Saul J, Clothier B, Nyman JA, Hammett P, Joseph AM. Proactive tobacco treatment offering free nicotine replacement therapy and telephone counselling for socioeconomically disadvantaged smokers: a randomised clinical trial. Thorax. 2016 May;71(5):446-53. doi: 10.1136/thoraxjnl-2015-207904. Epub 2016 Mar 1.
Fu SS, van Ryn M, Burgess DJ, Nelson D, Clothier B, Thomas JL, Nyman JA, Joseph AM. Proactive tobacco treatment for low income smokers: study protocol of a randomized controlled trial. BMC Public Health. 2014 Apr 9;14:337. doi: 10.1186/1471-2458-14-337.
Other Identifiers
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0909S72235
Identifier Type: OTHER
Identifier Source: secondary_id
2009NTLS064
Identifier Type: -
Identifier Source: org_study_id
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