Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)
20. juli 2022 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
1094
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Delaware
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Newark, Delaware, Forente stater, 19713
- Helen F Graham Cancer Center
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Georgia
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Augusta, Georgia, Forente stater, 30912
- Augusta University Medical Center
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Savannah, Georgia, Forente stater, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Hawaii
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Honolulu, Hawaii, Forente stater, 96859
- Tripler Army Medical Center
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Illinois
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Mount Vernon, Illinois, Forente stater, 62864
- Good Samaritan Regional Health Center
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Urbana, Illinois, Forente stater, 61801
- Carle Cancer Center
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Iowa
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Ames, Iowa, Forente stater, 50010
- McFarland Clinic PC - Ames
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Des Moines, Iowa, Forente stater, 50314
- Mercy Medical Center - Des Moines
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Louisiana
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Shreveport, Louisiana, Forente stater, 71103
- LSU Health Sciences Center at Shreveport
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Michigan
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Ann Arbor, Michigan, Forente stater, 48106
- Saint Joseph Mercy Hospital
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Grand Rapids, Michigan, Forente stater, 49503
- Spectrum Health at Butterworth Campus
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Royal Oak, Michigan, Forente stater, 48073
- William Beaumont Hospital-Royal Oak
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Minnesota
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Waconia, Minnesota, Forente stater, 55387
- Ridgeview Medical Center
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Missouri
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Ballwin, Missouri, Forente stater, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar, Missouri, Forente stater, 65613
- Central Care Cancer Center - Bolivar
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Branson, Missouri, Forente stater, 65616
- Cox Cancer Center Branson
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Joplin, Missouri, Forente stater, 64804
- Freeman Health System
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Joplin, Missouri, Forente stater, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Forente stater, 65401
- Delbert Day Cancer Institute at PCRMC
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Rolla, Missouri, Forente stater, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Louis, Missouri, Forente stater, 63131
- Missouri Baptist Medical Center
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Saint Louis, Missouri, Forente stater, 63141
- Mercy Hospital Saint Louis
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Saint Louis, Missouri, Forente stater, 63109
- Saint Louis Cancer and Breast Institute-South City
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Springfield, Missouri, Forente stater, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Forente stater, 65804
- Mercy Hospital Springfield
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Washington, Missouri, Forente stater, 63090
- Mercy Hospital Washington
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Nevada
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Las Vegas, Nevada, Forente stater, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, Forente stater, 89503
- Saint Mary's Regional Medical Center
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New York
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Bronx, New York, Forente stater, 10467
- Montefiore Medical Center - Moses Campus
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27103
- Novant Health Forsyth Medical Center
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North Dakota
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Fargo, North Dakota, Forente stater, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, Forente stater, 58103
- Sanford South University Medical Center
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Ohio
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Chillicothe, Ohio, Forente stater, 45601
- Adena Regional Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73120
- Mercy Hospital Oklahoma City
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Pennsylvania
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Danville, Pennsylvania, Forente stater, 17822
- Geisinger Medical Center
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South Carolina
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Boiling Springs, South Carolina, Forente stater, 29316
- Prisma Health Cancer Institute - Spartanburg
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Clinton, South Carolina, Forente stater, 29325
- Prisma Health Cancer Institute - Laurens
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Easley, South Carolina, Forente stater, 29640
- Prisma Health Cancer Institute - Easley
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Greenville, South Carolina, Forente stater, 29605
- Prisma Health Cancer Institute - Faris
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Greenville, South Carolina, Forente stater, 29615
- Prisma Health Cancer Institute - Eastside
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Greenville, South Carolina, Forente stater, 29605
- Prisma Health Cancer Institute - Butternut
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Greenville, South Carolina, Forente stater, 29605
- Prisma Health Greenville Memorial Hospital
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Greer, South Carolina, Forente stater, 29650
- Prisma Health Cancer Institute - Greer
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Seneca, South Carolina, Forente stater, 29672
- Prisma Health Cancer Institute - Seneca
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Tennessee
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Memphis, Tennessee, Forente stater, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Virginia
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Richmond, Virginia, Forente stater, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Forente stater, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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La Crosse, Wisconsin, Forente stater, 54601
- Gundersen Lutheran Medical Center
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Milwaukee, Wisconsin, Forente stater, 53215
- Aurora Saint Luke's Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Ingen inngripen: 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) |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
Tidsramme: 6 months (after baseline)
|
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.
|
6 months (after baseline)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Salivary Cotinine Test for Non-Smokers
Tidsramme: 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
Tidsramme: 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
Tidsramme: <= 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Studiestol: Kristie Foley, PhD, Wake Forest University Health Sciences
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
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- 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.
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Hjelpsomme linker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2018
Primær fullføring (Faktiske)
22. februar 2021
Studiet fullført (Faktiske)
22. februar 2021
Datoer for studieregistrering
Først innsendt
19. september 2017
Først innsendt som oppfylte QC-kriteriene
19. september 2017
Først lagt ut (Faktiske)
25. september 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
25. juli 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. juli 2022
Sist bekreftet
1. juli 2022
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- IRB00040071
- 1R01CA207158-01 (U.S. NIH-stipend/kontrakt)
- REBAWF-20817CD (Annen identifikator: NCI)
- NCI-2017-01669 (Registeridentifikator: NCI CTRP)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
see NIH policy
Tilgangskriterier for IPD-deling
request using uniform resource locator (URL) below
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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