Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)
20 luglio 2022 aggiornato da: Wake Forest University Health Sciences
Implementation Of Smoking Cessation Services Within NCI NCORP Community Sites With Organized Lung Cancer Screening Programs
Evaluate a multi-faceted training program to improve short-term smoking cessation rates (<14 days post-visit) and short (3 months) and sustained abstinence (6 months) among 1,114 enrolled smokers who present for low-dose computed tomography (LDCT) lung cancer screening in 26 community-based practices.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
We utilize an effectiveness-implementation hybrid design, employing a cluster, randomized control trial of community-based NCORP sites to study the effectiveness of a multi-faceted intervention to improve smoking cessation among lung cancer screening patients, as well as dissemination and implementation (D&I) science to optimize and accelerate translation of findings into clinical practice.
We will: (1) Evaluate a multi-faceted training program to improve short-term smoking cessation rates (1-week post-visit) and sustained abstinence (6 months) among 1,114 enrolled smokers (557 in each trial arm) who present for LDCT lung cancer screening in community-based lung cancer screening practices; (2) Characterize the adoption and adaptation of the evidence-based tobacco cessation strategies in 26 community-based LDCT lung cancer screening programs; and (3) Develop and evaluate an implementation toolkit for integrating evidence-based tobacco cessation strategies in community-based LDCT lung cancer screening programs.
Qualitative data will be collected from key informants at participating screening programs during and after intervention implementation.
Quantitative survey data (baseline, <14 days, 3 months, and 6 months) and saliva specimens (6 months only) will be collected from smoking patients receiving screening within these programs.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1094
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Delaware
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Newark, Delaware, Stati Uniti, 19713
- Helen F Graham Cancer Center
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Georgia
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Augusta, Georgia, Stati Uniti, 30912
- Augusta University Medical Center
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Savannah, Georgia, Stati Uniti, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Hawaii
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Honolulu, Hawaii, Stati Uniti, 96859
- Tripler Army Medical Center
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Illinois
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Mount Vernon, Illinois, Stati Uniti, 62864
- Good Samaritan Regional Health Center
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Urbana, Illinois, Stati Uniti, 61801
- Carle Cancer Center
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Iowa
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Ames, Iowa, Stati Uniti, 50010
- McFarland Clinic PC - Ames
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Des Moines, Iowa, Stati Uniti, 50314
- Mercy Medical Center - Des Moines
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Louisiana
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Shreveport, Louisiana, Stati Uniti, 71103
- LSU Health Sciences Center at Shreveport
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48106
- Saint Joseph Mercy Hospital
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Grand Rapids, Michigan, Stati Uniti, 49503
- Spectrum Health at Butterworth Campus
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Royal Oak, Michigan, Stati Uniti, 48073
- William Beaumont Hospital-Royal Oak
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Minnesota
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Waconia, Minnesota, Stati Uniti, 55387
- Ridgeview Medical Center
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Missouri
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Ballwin, Missouri, Stati Uniti, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar, Missouri, Stati Uniti, 65613
- Central Care Cancer Center - Bolivar
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Branson, Missouri, Stati Uniti, 65616
- Cox Cancer Center Branson
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Joplin, Missouri, Stati Uniti, 64804
- Freeman Health System
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Joplin, Missouri, Stati Uniti, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Stati Uniti, 65401
- Delbert Day Cancer Institute at PCRMC
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Rolla, Missouri, Stati Uniti, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Louis, Missouri, Stati Uniti, 63131
- Missouri Baptist Medical Center
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Saint Louis, Missouri, Stati Uniti, 63141
- Mercy Hospital Saint Louis
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Saint Louis, Missouri, Stati Uniti, 63109
- Saint Louis Cancer and Breast Institute-South City
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Springfield, Missouri, Stati Uniti, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Stati Uniti, 65804
- Mercy Hospital Springfield
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Washington, Missouri, Stati Uniti, 63090
- Mercy Hospital Washington
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Nevada
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Las Vegas, Nevada, Stati Uniti, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, Stati Uniti, 89503
- Saint Mary's Regional Medical Center
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New York
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Bronx, New York, Stati Uniti, 10467
- Montefiore Medical Center - Moses Campus
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North Carolina
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Winston-Salem, North Carolina, Stati Uniti, 27103
- Novant Health Forsyth Medical Center
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North Dakota
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Fargo, North Dakota, Stati Uniti, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, Stati Uniti, 58103
- Sanford South University Medical Center
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Ohio
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Chillicothe, Ohio, Stati Uniti, 45601
- Adena Regional Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Stati Uniti, 73120
- Mercy Hospital Oklahoma City
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Pennsylvania
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Danville, Pennsylvania, Stati Uniti, 17822
- Geisinger Medical Center
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South Carolina
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Boiling Springs, South Carolina, Stati Uniti, 29316
- Prisma Health Cancer Institute - Spartanburg
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Clinton, South Carolina, Stati Uniti, 29325
- Prisma Health Cancer Institute - Laurens
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Easley, South Carolina, Stati Uniti, 29640
- Prisma Health Cancer Institute - Easley
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Greenville, South Carolina, Stati Uniti, 29605
- Prisma Health Cancer Institute - Faris
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Greenville, South Carolina, Stati Uniti, 29615
- Prisma Health Cancer Institute - Eastside
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Greenville, South Carolina, Stati Uniti, 29605
- Prisma Health Cancer Institute - Butternut
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Greenville, South Carolina, Stati Uniti, 29605
- Prisma Health Greenville Memorial Hospital
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Greer, South Carolina, Stati Uniti, 29650
- Prisma Health Cancer Institute - Greer
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Seneca, South Carolina, Stati Uniti, 29672
- Prisma Health Cancer Institute - Seneca
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Tennessee
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Memphis, Tennessee, Stati Uniti, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Virginia
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Richmond, Virginia, Stati Uniti, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Stati Uniti, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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La Crosse, Wisconsin, Stati Uniti, 54601
- Gundersen Lutheran Medical Center
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Milwaukee, Wisconsin, Stati Uniti, 53215
- Aurora Saint Luke's Medical Center
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Agrees to have NCORP research personnel serve as the study liaison and another person to serve as the cessation program champion.
- Agrees to participate in all aspects of the intervention, randomization, and evaluation.
- Agrees to participate in a confidential 1-on-1 semi-structured interview with the research team.
- Agrees to have the interview taped, transcribed and qualitatively analyzed.
- Age ≥18 years
- Potential participants will be screened using the following question: "Do you smoke cigarettes every day, some days, or not at all?" (BRFSS). A current smoker is anyone responds "every day" or "some days".
Exclusion Criteria:
- Current use (previous 30 days) of a tobacco dependence treatment including bupropion, varenicline, and nicotine replacement
- Individuals who use e-cigarettes and who are not smoking cigarettes. Dual users (those who use both e-cigarettes and cigarettes) will still be included in the trial.
- The presence of a physical or cognitive impairment that would prevent a person from engaging in survey research (such as blindness, deafness, or dementia).
- Individual has already completed the intended LDCT lung cancer screening for this study.
- Non-English speaking participants.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Intervention
Training of Lung Cancer Screening Personnel on implementation of the United States Public Health Service (US PHS) Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, <14 days, 3 months, and 6 months) |
Training of Lung Cancer Screening Personnel on implementation of the US PHS Guidelines for Smoking Cessation and Performance Coaching during Implementation Phase of the Study Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation. |
|
Nessun intervento: Usual Care
No training or performance coaching calls on personnel, just usual clinic practice. Data collection from Patients: demographics, health status, smoking history, quitting behavior, perceptions of lung cancer risk and worry, impact of screening on tobacco use behavior, and exposure to the intervention. (baseline, <14 days, 3 months, and 6 months) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
Lasso di tempo: 6 months (after baseline)
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7-day sustained smoking abstinence will be measured by the question "Have you smoked a cigarette (or other tobacco products), even a puff, in the last 7 days?" in patient survey.
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6 months (after baseline)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Salivary Cotinine Test for Non-Smokers
Lasso di tempo: 6 months (after baseline)
|
7-day Sustained Smoking abstinence will be validated using a salivary cotinine test in non smokers.
Abstinence will be determined by percentage of smokers whose tests come back negative for cotinine.
Low levels of cotinine less than 15 milligrams per milliliter (mg/mL) would suggest true smoking cessation and levels higher than or equal to 15 mg/mL would suggest they are still smoking.
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6 months (after baseline)
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Short-term Smoking Abstinence - Patient Survey
Lasso di tempo: 3 months (after baseline)
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Short-tem smoking abstinence will be measured as part of the patient survey as the percentage of patients who report that they have not smoked.
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3 months (after baseline)
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Total Number of Services Participant Reported Received at 14 Days
Lasso di tempo: <= 14 days after baseline
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Fidelity to the intervention will be measured by a patient survey that asks patients if they received up to 18 cessation services during the screening visit.
This is the total each participant reported receiving and can range from 0 to 18, with higher values representing more services.
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<= 14 days after baseline
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Cattedra di studio: Kristie Foley, PhD, Wake Forest University Health Sciences
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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- Bock BC, Papandonatos GD, de Dios MA, Abrams DB, Azam MM, Fagan M, Sweeney PJ, Stein MD, Niaura R. Tobacco cessation among low-income smokers: motivational enhancement and nicotine patch treatment. Nicotine Tob Res. 2014 Apr;16(4):413-22. doi: 10.1093/ntr/ntt166. Epub 2013 Oct 30.
- McMahon PM, Kong CY, Bouzan C, Weinstein MC, Cipriano LE, Tramontano AC, Johnson BE, Weeks JC, Gazelle GS. Cost-effectiveness of computed tomography screening for lung cancer in the United States. J Thorac Oncol. 2011 Nov;6(11):1841-8. doi: 10.1097/JTO.0b013e31822e59b3.
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- Foley KL, Pockey JR, Helme DW, Song EY, Stewart K, Jones C, Spangler JG, Sutfin EL. Integrating evidence-based tobacco cessation interventions in free medical clinics: opportunities and challenges. Health Promot Pract. 2012 Sep;13(5):687-95. doi: 10.1177/1524839911433465. Epub 2012 Mar 30.
- Pockey JR, Song EY, Sutfin EL, Spangler JG, Jones C, Helme DW, Foley KL. The need for tobacco cessation in a free clinic population. Addict Behav. 2012 Dec;37(12):1299-302. doi: 10.1016/j.addbeh.2012.03.032. Epub 2012 Jul 4.
- Error in Text and Table. Primary Care Provider-Delivered Smoking Cessation Interventions and Smoking Cessation Among Participants in the National Lung Screening Trial. JAMA Intern Med. 2015 Sep;175(9):1587-8. doi: 10.1001/jamainternmed.2015.4006. No abstract available.
- Fiore MC, Goplerud E, Schroeder SA. The Joint Commission's new tobacco-cessation measures--will hospitals do the right thing? N Engl J Med. 2012 Mar 29;366(13):1172-4. doi: 10.1056/NEJMp1115176. Epub 2012 Mar 14. No abstract available.
- G.A. Colditz. The promise and challenges of dissemination and implementation research. In: Dissemination and Implementation Research in Health. New York: Oxford University Press; 2012.
- Balas EA, Boren SA. Managing Clinical Knowledge for Health Care Improvement. Yearb Med Inform. 2000;(1):65-70. No abstract available.
- Brownson RC, Jones E. Bridging the gap: translating research into policy and practice. Prev Med. 2009 Oct;49(4):313-5. doi: 10.1016/j.ypmed.2009.06.008. Epub 2009 Jun 22.
- Goulart BH, Ramsey SD. Moving beyond the national lung screening trial: discussing strategies for implementation of lung cancer screening programs. Oncologist. 2013;18(8):941-6. doi: 10.1634/theoncologist.2013-0007. Epub 2013 Jul 19.
- Marcus PM. Lung cancer screening with low dose computed tomography (LDCT): looking back and moving forward. Ann Transl Med. 2015 May;3(Suppl 1):S41. doi: 10.3978/j.issn.2305-5839.2015.03.36. No abstract available.
- Kent EE, Mitchell SA, Castro KM, DeWalt DA, Kaluzny AD, Hautala JA, Grad O, Ballard RM, McCaskill-Stevens WJ, Kramer BS, Clauser SB. Cancer Care Delivery Research: Building the Evidence Base to Support Practice Change in Community Oncology. J Clin Oncol. 2015 Aug 20;33(24):2705-11. doi: 10.1200/JCO.2014.60.6210. Epub 2015 Jul 20.
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- Spangler JG, Song EY, Pockey JR, Sutfin EL, Helme DW, Jones C, Foley KL. Predictors of Clinician Tobacco Intervention Counseling in Six North Carolina Free Clinics. Tob Use Insights. 2012 Jul 10;20125:11-16. doi: 10.4137/TUI.S9350.
- McNamara RS, Y Song E, Reboussin BA, Spangler J, Pockey JR, Kimes C, Foley KL, Sutfin EL. Motivational interviewing intervention with college student tobacco users: providers' beliefs and behaviors. J Am Coll Health. 2015;63(4):286-90. doi: 10.1080/07448481.2014.1003376.
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Collegamenti utili
- Medicare Coverage Database - Centers for Medicare & Medicaid Services
- Bradley EH, Pallas S, Bashyal C, Berman P, Curry L. Developing Strategies for Improving Health Care Delivery : Guide to Concepts, Determinants, Measurement, and Intervention Design. June 2010.
- Johnson. HR at MIT | Learning & Development | What is Coaching?
- Donner A, Klar N. Design and Analysis of Cluster Randomization Trials in Health Research. London: Arnold; 2000
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 giugno 2018
Completamento primario (Effettivo)
22 febbraio 2021
Completamento dello studio (Effettivo)
22 febbraio 2021
Date di iscrizione allo studio
Primo inviato
19 settembre 2017
Primo inviato che soddisfa i criteri di controllo qualità
19 settembre 2017
Primo Inserito (Effettivo)
25 settembre 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
25 luglio 2022
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 luglio 2022
Ultimo verificato
1 luglio 2022
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IRB00040071
- 1R01CA207158-01 (Sovvenzione/contratto NIH degli Stati Uniti)
- REBAWF-20817CD (Altro identificatore: NCI)
- NCI-2017-01669 (Identificatore di registro: NCI CTRP)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Wake Forest (WF) NCORP Research Base (RB) is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html).
As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI National Clinical Trials Network (NCTN)/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials (https://nctn-data-archive.nci.nih.gov/).
This will become the primary means for sharing raw data and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide.
Periodo di condivisione IPD
see NIH policy
Criteri di accesso alla condivisione IPD
request using uniform resource locator (URL) below
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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