Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)
20 de julio de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
1094
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Delaware
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Newark, Delaware, Estados Unidos, 19713
- Helen F Graham Cancer Center
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Georgia
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Augusta, Georgia, Estados Unidos, 30912
- Augusta University Medical Center
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Savannah, Georgia, Estados Unidos, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Hawaii
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Honolulu, Hawaii, Estados Unidos, 96859
- Tripler Army Medical Center
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Illinois
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Mount Vernon, Illinois, Estados Unidos, 62864
- Good Samaritan Regional Health Center
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Urbana, Illinois, Estados Unidos, 61801
- Carle Cancer Center
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Iowa
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Ames, Iowa, Estados Unidos, 50010
- McFarland Clinic PC - Ames
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Des Moines, Iowa, Estados Unidos, 50314
- Mercy Medical Center - Des Moines
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Louisiana
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Shreveport, Louisiana, Estados Unidos, 71103
- LSU Health Sciences Center at Shreveport
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48106
- Saint Joseph Mercy Hospital
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Grand Rapids, Michigan, Estados Unidos, 49503
- Spectrum Health at Butterworth Campus
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Royal Oak, Michigan, Estados Unidos, 48073
- William Beaumont Hospital-Royal Oak
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Minnesota
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Waconia, Minnesota, Estados Unidos, 55387
- Ridgeview Medical Center
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Missouri
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Ballwin, Missouri, Estados Unidos, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar, Missouri, Estados Unidos, 65613
- Central Care Cancer Center - Bolivar
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Branson, Missouri, Estados Unidos, 65616
- Cox Cancer Center Branson
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Joplin, Missouri, Estados Unidos, 64804
- Freeman Health System
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Joplin, Missouri, Estados Unidos, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Estados Unidos, 65401
- Delbert Day Cancer Institute at PCRMC
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Rolla, Missouri, Estados Unidos, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Louis, Missouri, Estados Unidos, 63131
- Missouri Baptist Medical Center
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Saint Louis, Missouri, Estados Unidos, 63141
- Mercy Hospital Saint Louis
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Saint Louis, Missouri, Estados Unidos, 63109
- Saint Louis Cancer and Breast Institute-South City
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Springfield, Missouri, Estados Unidos, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Estados Unidos, 65804
- Mercy Hospital Springfield
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Washington, Missouri, Estados Unidos, 63090
- Mercy Hospital Washington
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, Estados Unidos, 89503
- Saint Mary's Regional Medical Center
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New York
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Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center - Moses Campus
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Novant Health Forsyth Medical Center
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North Dakota
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Fargo, North Dakota, Estados Unidos, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, Estados Unidos, 58103
- Sanford South University Medical Center
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Ohio
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Chillicothe, Ohio, Estados Unidos, 45601
- Adena Regional Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73120
- Mercy Hospital Oklahoma City
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Pennsylvania
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Danville, Pennsylvania, Estados Unidos, 17822
- Geisinger Medical Center
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South Carolina
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Boiling Springs, South Carolina, Estados Unidos, 29316
- Prisma Health Cancer Institute - Spartanburg
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Clinton, South Carolina, Estados Unidos, 29325
- Prisma Health Cancer Institute - Laurens
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Easley, South Carolina, Estados Unidos, 29640
- Prisma Health Cancer Institute - Easley
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Greenville, South Carolina, Estados Unidos, 29605
- Prisma Health Cancer Institute - Faris
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Greenville, South Carolina, Estados Unidos, 29615
- Prisma Health Cancer Institute - Eastside
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Greenville, South Carolina, Estados Unidos, 29605
- Prisma Health Cancer Institute - Butternut
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Greenville, South Carolina, Estados Unidos, 29605
- Prisma Health Greenville Memorial Hospital
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Greer, South Carolina, Estados Unidos, 29650
- Prisma Health Cancer Institute - Greer
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Seneca, South Carolina, Estados Unidos, 29672
- Prisma Health Cancer Institute - Seneca
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Tennessee
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Memphis, Tennessee, Estados Unidos, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Virginia
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Richmond, Virginia, Estados Unidos, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Estados Unidos, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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La Crosse, Wisconsin, Estados Unidos, 54601
- Gundersen Lutheran Medical Center
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Milwaukee, Wisconsin, Estados Unidos, 53215
- Aurora Saint Luke's Medical Center
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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. |
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Sin intervención: 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) |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Salivary Cotinine Test for Non-Smokers
Periodo de tiempo: 6 months (after baseline)
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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
Periodo de tiempo: 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
Periodo de tiempo: <= 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
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Kristie Foley, PhD, Wake Forest University Health Sciences
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
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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.
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- 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.
- Etter JF, Neidhart E, Bertrand S, Malafosse A, Bertrand D. Collecting saliva by mail for genetic and cotinine analyses in participants recruited through the Internet. Eur J Epidemiol. 2005;20(10):833-8. doi: 10.1007/s10654-005-2148-7.
- 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.
- 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.
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- 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.
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- 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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Enlaces Útiles
- 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
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de junio de 2018
Finalización primaria (Actual)
22 de febrero de 2021
Finalización del estudio (Actual)
22 de febrero de 2021
Fechas de registro del estudio
Enviado por primera vez
19 de septiembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
19 de septiembre de 2017
Publicado por primera vez (Actual)
25 de septiembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de julio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
20 de julio de 2022
Última verificación
1 de julio de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IRB00040071
- 1R01CA207158-01 (Subvención/contrato del NIH de EE. UU.)
- REBAWF-20817CD (Otro identificador: NCI)
- NCI-2017-01669 (Identificador de registro: NCI CTRP)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
see NIH policy
Criterios de acceso compartido de IPD
request using uniform resource locator (URL) below
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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