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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA207048-01 | U.S. NIH Grant/Contract | View source |
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Low Study Accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Truth Initiative | OTHER |
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This study will evaluate the impact of a proactive, EHR-supported enrollment strategy that links LDCT-eligible smokers with an evidence-based intervention comprised of a web-based program and integrated text messaging. The goal is to provide actionable findings about how to most effectively and cost efficiently promote abstinence in LDCT clinics.
Using a 3-arm randomized trial design with repeated measures at 1, 3, 6, and 12 months, the study will randomize N=1650 smokers who present for LDCT lung cancer screening to an passive referral usual care control condition, proactive referral to a digital cessation intervention that combines web and text messaging, or proactive referral to a digital cessation intervention combined with Tobacco Treatment Specialist counseling. The Study will examine overall effectiveness of the interventions in promoting abstinence, the impact of proactive referral to treatment, and the total cost and cost effectiveness of the interventions. The Study will also examine the representativeness of the enrolled sample and explore barriers and facilitators to intervention adoption with LDCT clinic leaders. The trial is structured as a practical clinical trial to answer key questions of direct relevance to LDCT decision-makers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC | Active Comparator | Usual Care |
|
| WEB+TXT | Active Comparator | Digital Intervention |
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| WEB+TXT+TTS | Active Comparator | Digital plus Counseling Intervention |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Behavioral | Brief cessation counseling |
| |
| WEB+TXT |
| Measure | Description | Time Frame |
|---|---|---|
| smoking abstinence | biochemically confirmed 12 month smoking abstinence of WEB+TXT; | 12 months |
| smoking abstinence | biochemically confirmed 12 month smoking abstinence of WEB+TXT+TTS ; | 12 months |
| smoking abstinence | biochemically confirmed 12 month smoking abstinence of UC; | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James T Hays, MD | Mayo Clinic | Principal Investigator |
| David E Midthun, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29179734 | Background | Graham AL, Burke MV, Jacobs MA, Cha S, Croghan IT, Schroeder DR, Moriarty JP, Borah BJ, Rasmussen DF, Brookover MJ, Suesse DB, Midthun DE, Hays JT. An integrated digital/clinical approach to smoking cessation in lung cancer screening: study protocol for a randomized controlled trial. Trials. 2017 Nov 28;18(1):568. doi: 10.1186/s13063-017-2312-x. | |
| Background | Burke, MV; Graham, AL; Midthun, DE; Hays, JT; Efficacia delle nuove tecnologie digitali di rete per la smoking cessation nello screening del tumore polmonare (Effectiveness of new digital technologies for smoking cessation in lung cancer screening). Tabaccologia 2019; 2:21-25 |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Behavioral |
Access to Become an Ex website plus text messaging |
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| WEB+TXT+TTS | Behavioral | Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist |
|