Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)
2022年7月20日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
1094
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Delaware
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Newark、Delaware、美国、19713
- Helen F Graham Cancer Center
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Georgia
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Augusta、Georgia、美国、30912
- Augusta University Medical Center
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Savannah、Georgia、美国、31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Hawaii
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Honolulu、Hawaii、美国、96859
- Tripler Army Medical Center
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Illinois
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Mount Vernon、Illinois、美国、62864
- Good Samaritan Regional Health Center
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Urbana、Illinois、美国、61801
- Carle Cancer Center
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Iowa
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Ames、Iowa、美国、50010
- McFarland Clinic PC - Ames
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Des Moines、Iowa、美国、50314
- Mercy Medical Center - Des Moines
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Louisiana
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Shreveport、Louisiana、美国、71103
- LSU Health Sciences Center at Shreveport
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Michigan
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Ann Arbor、Michigan、美国、48106
- Saint Joseph Mercy Hospital
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Grand Rapids、Michigan、美国、49503
- Spectrum Health at Butterworth Campus
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Royal Oak、Michigan、美国、48073
- William Beaumont Hospital-Royal Oak
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Minnesota
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Waconia、Minnesota、美国、55387
- Ridgeview Medical Center
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Missouri
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Ballwin、Missouri、美国、63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar、Missouri、美国、65613
- Central Care Cancer Center - Bolivar
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Branson、Missouri、美国、65616
- Cox Cancer Center Branson
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Joplin、Missouri、美国、64804
- Freeman Health System
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Joplin、Missouri、美国、64804
- Mercy Hospital Joplin
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Rolla、Missouri、美国、65401
- Delbert Day Cancer Institute at PCRMC
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Rolla、Missouri、美国、65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Louis、Missouri、美国、63131
- Missouri Baptist Medical Center
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Saint Louis、Missouri、美国、63141
- Mercy Hospital Saint Louis
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Saint Louis、Missouri、美国、63109
- Saint Louis Cancer and Breast Institute-South City
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Springfield、Missouri、美国、65807
- CoxHealth South Hospital
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Springfield、Missouri、美国、65804
- Mercy Hospital Springfield
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Washington、Missouri、美国、63090
- Mercy Hospital Washington
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Nevada
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Las Vegas、Nevada、美国、89102
- University Medical Center of Southern Nevada
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Reno、Nevada、美国、89503
- Saint Mary's Regional Medical Center
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New York
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Bronx、New York、美国、10467
- Montefiore Medical Center - Moses Campus
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North Carolina
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Winston-Salem、North Carolina、美国、27103
- Novant Health Forsyth Medical Center
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North Dakota
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Fargo、North Dakota、美国、58122
- Sanford Roger Maris Cancer Center
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Fargo、North Dakota、美国、58103
- Sanford South University Medical Center
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Ohio
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Chillicothe、Ohio、美国、45601
- Adena Regional Medical Center
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Oklahoma
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Oklahoma City、Oklahoma、美国、73120
- Mercy Hospital Oklahoma City
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Pennsylvania
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Danville、Pennsylvania、美国、17822
- Geisinger Medical Center
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South Carolina
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Boiling Springs、South Carolina、美国、29316
- Prisma Health Cancer Institute - Spartanburg
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Clinton、South Carolina、美国、29325
- Prisma Health Cancer Institute - Laurens
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Easley、South Carolina、美国、29640
- Prisma Health Cancer Institute - Easley
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Greenville、South Carolina、美国、29605
- Prisma Health Cancer Institute - Faris
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Greenville、South Carolina、美国、29615
- Prisma Health Cancer Institute - Eastside
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Greenville、South Carolina、美国、29605
- Prisma Health Cancer Institute - Butternut
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Greenville、South Carolina、美国、29605
- Prisma Health Greenville Memorial Hospital
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Greer、South Carolina、美国、29650
- Prisma Health Cancer Institute - Greer
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Seneca、South Carolina、美国、29672
- Prisma Health Cancer Institute - Seneca
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Tennessee
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Memphis、Tennessee、美国、38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Virginia
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Richmond、Virginia、美国、23235
- VCU Massey Cancer Center at Stony Point
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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La Crosse、Wisconsin、美国、54601
- Gundersen Lutheran Medical Center
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Milwaukee、Wisconsin、美国、53215
- Aurora Saint Luke's Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
无干预：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) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Salivary Cotinine Test for Non-Smokers
大体时间：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
大体时间：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
大体时间：<= 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
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Kristie Foley, PhD、Wake Forest University Health Sciences
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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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.
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- 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.
- Bradley EH, Curry LA, Ramanadhan S, Rowe L, Nembhard IM, Krumholz HM. Research in action: using positive deviance to improve quality of health care. Implement Sci. 2009 May 8;4:25. doi: 10.1186/1748-5908-4-25.
- 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.
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- 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.
- Greenhalgh T, Robert G, Macfarlane F, Bate P, Kyriakidou O, Peacock R. Storylines of research in diffusion of innovation: a meta-narrative approach to systematic review. Soc Sci Med. 2005 Jul;61(2):417-30. doi: 10.1016/j.socscimed.2004.12.001. Epub 2005 Jan 26.
- Kowalski K, Casper C. The coaching process: an effective tool for professional development. Nurs Adm Q. 2007 Apr-Jun;31(2):171-9. doi: 10.1097/01.NAQ.0000264867.73873.1a.
- 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.
- D'Agostino RB, Rubin DB. Estimating and Using Propensity Scores with Partially Missing Data. J Am Stat Assoc. 2000;95(451):749-759. doi:10.2307/2669455.
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有用的网址
- 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
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年6月1日
初级完成 (实际的)
2021年2月22日
研究完成 (实际的)
2021年2月22日
研究注册日期
首次提交
2017年9月19日
首先提交符合 QC 标准的
2017年9月19日
首次发布 (实际的)
2017年9月25日
研究记录更新
最后更新发布 (实际的)
2022年7月25日
上次提交的符合 QC 标准的更新
2022年7月20日
最后验证
2022年7月1日
更多信息
与本研究相关的术语
其他研究编号
- IRB00040071
- 1R01CA207158-01 (美国 NIH 拨款/合同)
- REBAWF-20817CD (其他标识符：NCI)
- NCI-2017-01669 (注册表标识符：NCI CTRP)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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.
IPD 共享时间框架
see NIH policy
IPD 共享访问标准
request using uniform resource locator (URL) below
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.