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| ID | Type | Description | Link |
|---|---|---|---|
| 0909S72235 | Other Identifier | IRB, University of Minnesota | |
| 1R01CA141527 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study uses a proactive outreach strategy, coupled with free nicotine replacement therapy (NRT) to increase the population impact of tobacco cessation treatment for diverse, low income smokers. Population impact is the product of treatment utilization (i.e., reach or exposure) and treatment efficacy (i.e., smoking abstinence rates among those who utilize treatment).
Participants will be randomized to receive either Usual (Reactive) Care or Proactive Outreach, Telephone Counseling and free nicotine replacement therapy (NRT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO+NRT+TC | Experimental | 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) |
|
| Usual Care (UC) | Active Comparator | Usual (standard) care - Smoking cessation products: patch, gum, lozenge, inhaler and nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| proactive outreach (PRO) | Other | a mailed invitation letter followed by telephone outreach |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Results in Abstinence Rates | Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level smoking abstinence rates among a diverse population of low income smokers. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Results in Treatment Utilization | Compare the effect of proactive outreach combined with free NRT and telephone counseling (PRO+NRT+TC) to usual care (UC) on population-level tobacco treatment utilization rates among a diverse population of low income smokers. | 1 Year |
| Cost-Effectiveness of Program |
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Inclusion Criteria:
exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven Fu, M.D. | Veterans Administration Hospital | Principal Investigator |
| Anne Joseph, MD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Steven Fu, M.D. | Minneapolis | Minnesota | 55417 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32614201 | Derived | 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. | |
| 31363948 | Derived | 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. |
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| ID | Term |
|---|---|
| D020340 | Tobacco Use Cessation |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| telephone counseling (TC) |
| Other |
free telephone counseling |
|
| Nicotine replacement therapy (NRT) | Other | free nicotine replacement therapy (NRT) |
|
| Usual care (UC) | Other | nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray) |
|
Determine the cost-effectiveness of PRO+NRT+TC compared with UC. |
| 1 Year |
| 26931362 | Derived | 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. |
| 24716466 | Derived | 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. |