Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)
20 lipca 2022 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
1094
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Delaware
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Newark, Delaware, Stany Zjednoczone, 19713
- Helen F Graham Cancer Center
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Georgia
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Augusta, Georgia, Stany Zjednoczone, 30912
- Augusta University Medical Center
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Savannah, Georgia, Stany Zjednoczone, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Hawaii
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Honolulu, Hawaii, Stany Zjednoczone, 96859
- Tripler Army Medical Center
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Illinois
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Mount Vernon, Illinois, Stany Zjednoczone, 62864
- Good Samaritan Regional Health Center
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Urbana, Illinois, Stany Zjednoczone, 61801
- Carle Cancer Center
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Iowa
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Ames, Iowa, Stany Zjednoczone, 50010
- McFarland Clinic PC - Ames
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Des Moines, Iowa, Stany Zjednoczone, 50314
- Mercy Medical Center - Des Moines
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Louisiana
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Shreveport, Louisiana, Stany Zjednoczone, 71103
- LSU Health Sciences Center at Shreveport
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Michigan
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Ann Arbor, Michigan, Stany Zjednoczone, 48106
- Saint Joseph Mercy Hospital
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Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Spectrum Health at Butterworth Campus
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Royal Oak, Michigan, Stany Zjednoczone, 48073
- William Beaumont Hospital-Royal Oak
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Minnesota
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Waconia, Minnesota, Stany Zjednoczone, 55387
- Ridgeview Medical Center
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Missouri
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Ballwin, Missouri, Stany Zjednoczone, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar, Missouri, Stany Zjednoczone, 65613
- Central Care Cancer Center - Bolivar
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Branson, Missouri, Stany Zjednoczone, 65616
- Cox Cancer Center Branson
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Joplin, Missouri, Stany Zjednoczone, 64804
- Freeman Health System
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Joplin, Missouri, Stany Zjednoczone, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Stany Zjednoczone, 65401
- Delbert Day Cancer Institute at PCRMC
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Rolla, Missouri, Stany Zjednoczone, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Louis, Missouri, Stany Zjednoczone, 63131
- Missouri Baptist Medical Center
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Saint Louis, Missouri, Stany Zjednoczone, 63141
- Mercy Hospital Saint Louis
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Saint Louis, Missouri, Stany Zjednoczone, 63109
- Saint Louis Cancer and Breast Institute-South City
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Springfield, Missouri, Stany Zjednoczone, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Stany Zjednoczone, 65804
- Mercy Hospital Springfield
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Washington, Missouri, Stany Zjednoczone, 63090
- Mercy Hospital Washington
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Nevada
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Las Vegas, Nevada, Stany Zjednoczone, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, Stany Zjednoczone, 89503
- Saint Mary's Regional Medical Center
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New York
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Bronx, New York, Stany Zjednoczone, 10467
- Montefiore Medical Center - Moses Campus
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North Carolina
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Winston-Salem, North Carolina, Stany Zjednoczone, 27103
- Novant Health Forsyth Medical Center
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North Dakota
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Fargo, North Dakota, Stany Zjednoczone, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, Stany Zjednoczone, 58103
- Sanford South University Medical Center
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Ohio
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Chillicothe, Ohio, Stany Zjednoczone, 45601
- Adena Regional Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
- Mercy Hospital Oklahoma City
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Pennsylvania
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Danville, Pennsylvania, Stany Zjednoczone, 17822
- Geisinger Medical Center
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South Carolina
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Boiling Springs, South Carolina, Stany Zjednoczone, 29316
- Prisma Health Cancer Institute - Spartanburg
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Clinton, South Carolina, Stany Zjednoczone, 29325
- Prisma Health Cancer Institute - Laurens
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Easley, South Carolina, Stany Zjednoczone, 29640
- Prisma Health Cancer Institute - Easley
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Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Faris
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Greenville, South Carolina, Stany Zjednoczone, 29615
- Prisma Health Cancer Institute - Eastside
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Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Butternut
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Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Greenville Memorial Hospital
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Greer, South Carolina, Stany Zjednoczone, 29650
- Prisma Health Cancer Institute - Greer
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Seneca, South Carolina, Stany Zjednoczone, 29672
- Prisma Health Cancer Institute - Seneca
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Tennessee
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Memphis, Tennessee, Stany Zjednoczone, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Virginia
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Richmond, Virginia, Stany Zjednoczone, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Stany Zjednoczone, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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La Crosse, Wisconsin, Stany Zjednoczone, 54601
- Gundersen Lutheran Medical Center
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Milwaukee, Wisconsin, Stany Zjednoczone, 53215
- Aurora Saint Luke's Medical Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Brak interwencji: 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) |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Salivary Cotinine Test for Non-Smokers
Ramy czasowe: 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
Ramy czasowe: 3 months (after baseline)
|
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
Ramy czasowe: <= 14 days after baseline
|
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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Współpracownicy
Śledczy
- Krzesło do nauki: Kristie Foley, PhD, Wake Forest University Health Sciences
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
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- SRNT Subcommittee on Biochemical Verification. Biochemical verification of tobacco use and cessation. Nicotine Tob Res. 2002 May;4(2):149-59. doi: 10.1080/14622200210123581. No abstract available.
- Greenhalgh T, Robert G, Macfarlane F, Bate P, Kyriakidou O. Diffusion of innovations in service organizations: systematic review and recommendations. Milbank Q. 2004;82(4):581-629. doi: 10.1111/j.0887-378X.2004.00325.x.
- Moyer VA; U.S. Preventive Services Task Force. Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771.
- Lewis JA, Petty WJ, Tooze JA, Miller DP, Chiles C, Miller AA, Bellinger C, Weaver KE. Low-Dose CT Lung Cancer Screening Practices and Attitudes among Primary Care Providers at an Academic Medical Center. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):664-70. doi: 10.1158/1055-9965.EPI-14-1241. Epub 2015 Jan 22.
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- Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.
- Strecher VJ, McClure J, Alexander G, Chakraborty B, Nair V, Konkel J, Greene S, Couper M, Carlier C, Wiese C, Little R, Pomerleau C, Pomerleau O. The role of engagement in a tailored web-based smoking cessation program: randomized controlled trial. J Med Internet Res. 2008 Nov 4;10(5):e36. doi: 10.2196/jmir.1002.
- Tong EK, Strouse R, Hall J, Kovac M, Schroeder SA. National survey of U.S. health professionals' smoking prevalence, cessation practices, and beliefs. Nicotine Tob Res. 2010 Jul;12(7):724-33. doi: 10.1093/ntr/ntq071. Epub 2010 May 27.
- Taylor DH Jr, Hasselblad V, Henley SJ, Thun MJ, Sloan FA. Benefits of smoking cessation for longevity. Am J Public Health. 2002 Jun;92(6):990-6. doi: 10.2105/ajph.92.6.990. Erratum In: Am J Public Health 2002 Sep;92(9):1389.
- National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
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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.
- Hermanson B, Omenn GS, Kronmal RA, Gersh BJ. Beneficial six-year outcome of smoking cessation in older men and women with coronary artery disease. Results from the CASS registry. N Engl J Med. 1988 Nov 24;319(21):1365-9. doi: 10.1056/NEJM198811243192101.
- Gellert C, Schottker B, Brenner H. Smoking and all-cause mortality in older people: systematic review and meta-analysis. Arch Intern Med. 2012 Jun 11;172(11):837-44. doi: 10.1001/archinternmed.2012.1397.
- Parsons A, Daley A, Begh R, Aveyard P. Influence of smoking cessation after diagnosis of early stage lung cancer on prognosis: systematic review of observational studies with meta-analysis. BMJ. 2010 Jan 21;340:b5569. doi: 10.1136/bmj.b5569.
- Black WC, Gareen IF, Soneji SS, Sicks JD, Keeler EB, Aberle DR, Naeim A, Church TR, Silvestri GA, Gorelick J, Gatsonis C; National Lung Screening Trial Research Team. Cost-effectiveness of CT screening in the National Lung Screening Trial. N Engl J Med. 2014 Nov 6;371(19):1793-802. doi: 10.1056/NEJMoa1312547.
- Zeliadt SB, Heffner JL, Sayre G, Klein DE, Simons C, Williams J, Reinke LF, Au DH. Attitudes and Perceptions About Smoking Cessation in the Context of Lung Cancer Screening. JAMA Intern Med. 2015 Sep;175(9):1530-7. doi: 10.1001/jamainternmed.2015.3558.
- Ostroff JS, Copeland A, Borderud SP, Li Y, Shelley DR, Henschke CI. Readiness of Lung Cancer Screening Sites to Deliver Smoking Cessation Treatment: Current Practices, Organizational Priority, and Perceived Barriers. Nicotine Tob Res. 2016 May;18(5):1067-75. doi: 10.1093/ntr/ntv177. Epub 2015 Sep 7.
- Okuyemi KS, Reitzel LR, Fagan P. Interventions to Reduce Tobacco-Related Health Disparities. Nicotine Tob Res. 2015 Aug;17(8):887-91. doi: 10.1093/ntr/ntv096. No abstract available.
- 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.
- Minasian LM, Carpenter WR, Weiner BJ, Anderson DE, McCaskill-Stevens W, Nelson S, Whitman C, Kelaghan J, O'Mara AM, Kaluzny AD. Translating research into evidence-based practice: the National Cancer Institute Community Clinical Oncology Program. Cancer. 2010 Oct 1;116(19):4440-9. doi: 10.1002/cncr.25248.
- Fiore M, Jaen C, Baker T, Bailey W, Benowitz N, Curry S. Treating Tobacco Use and Dependence: 2008 Update - TreatingTobaccoUseandDependence-2008Update.pdf. http://www.aafp.org/dam/AAFP/documents/patient_care/clinical_recommendations/TreatingTobaccoUseandDependence-2008Update.pdf. Published 2008. Accessed January 11, 2017.
- 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.
- Foley KL, Farmer DF, Petronis VM, Smith RG, McGraw S, Smith K, Carver CS, Avis N. A qualitative exploration of the cancer experience among long-term survivors: comparisons by cancer type, ethnicity, gender, and age. Psychooncology. 2006 Mar;15(3):248-58. doi: 10.1002/pon.942.
- Foley KL, Crandall SJ, George G, Roman M, Spangler JG. Reliability of a Smoking Cessation Risk Factor Interview Scale (SCRFIS) for use with standardized patient instructors. J Cancer Educ. 2003 Fall;18(3):134-41. doi: 10.1207/S15430154JCE1803_06.
- Spangler JG, George G, Foley KL, Crandall SJ. Tobacco intervention training: current efforts and gaps in US medical schools. JAMA. 2002 Sep 4;288(9):1102-9. doi: 10.1001/jama.288.9.1102.
- Foley KL, Sutfin EL. Availability of tobacco cessation services in free clinics. N C Med J. 2008 Jul-Aug;69(4):270-4.
- Holt DT, Armenakis AA, Feild HS, Harris SG. Readiness for Organizational Change: The Systematic Development of a Scale. J Appl Behav Sci. 2007;43(2):232-255. doi:10.1177/0021886306295295.
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- Papadakis S, Pipe AL, Reid RD, Tulloch H, Mullen KA, Assi R, Cole AG, Wells G. Effectiveness of performance coaching for enhancing rates of smoking cessation treatment delivery by primary care providers: Study protocol for a cluster randomized controlled trial. Contemp Clin Trials. 2015 Nov;45(Pt B):184-190. doi: 10.1016/j.cct.2015.08.013. Epub 2015 Sep 5.
- Glasgow RE, Green LW, Taylor MV, Stange KC. An evidence integration triangle for aligning science with policy and practice. Am J Prev Med. 2012 Jun;42(6):646-54. doi: 10.1016/j.amepre.2012.02.016.
- Newhouse R, Bobay K, Dykes PC, Stevens KR, Titler M. Methodology issues in implementation science. Med Care. 2013 Apr;51(4 Suppl 2):S32-40. doi: 10.1097/MLR.0b013e31827feeca.
- Omar RZ, Thompson SG. Analysis of a cluster randomized trial with binary outcome data using a multi-level model. Stat Med. 2000 Oct 15;19(19):2675-88. doi: 10.1002/1097-0258(20001015)19:193.0.co;2-a.
- Schauer GL, Malarcher AM, Asman KJ. Trends in the Average Age of Quitting Among U.S. Adult Cigarette Smokers. Am J Prev Med. 2015 Dec;49(6):939-44. doi: 10.1016/j.amepre.2015.06.028. Epub 2015 Sep 9.
- D'Agostino R, Karter A, Lang W, Walkup M, Morgan T. Examining the impact of missing data on propensity score estimation in determining the effectiveness of self-monitoring of blood glucose (SMBG). Health Serv Outcomes Res Methodol. 2001;2:291-315.
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Przydatne linki
- 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
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 czerwca 2018
Zakończenie podstawowe (Rzeczywisty)
22 lutego 2021
Ukończenie studiów (Rzeczywisty)
22 lutego 2021
Daty rejestracji na studia
Pierwszy przesłany
19 września 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 września 2017
Pierwszy wysłany (Rzeczywisty)
25 września 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
25 lipca 2022
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
20 lipca 2022
Ostatnia weryfikacja
1 lipca 2022
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- IRB00040071
- 1R01CA207158-01 (Grant/umowa NIH USA)
- REBAWF-20817CD (Inny identyfikator: NCI)
- NCI-2017-01669 (Identyfikator rejestru: NCI CTRP)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu 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.
Ramy czasowe udostępniania IPD
see NIH policy
Kryteria dostępu do udostępniania IPD
request using uniform resource locator (URL) below
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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