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Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)

20. juli 2022 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1094

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Helen F Graham Cancer Center
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Augusta University Medical Center
      • Savannah, Georgia, Forenede Stater, 31405
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96859
        • Tripler Army Medical Center
    • Illinois
      • Mount Vernon, Illinois, Forenede Stater, 62864
        • Good Samaritan Regional Health Center
      • Urbana, Illinois, Forenede Stater, 61801
        • Carle Cancer Center
    • Iowa
      • Ames, Iowa, Forenede Stater, 50010
        • McFarland Clinic PC - Ames
      • Des Moines, Iowa, Forenede Stater, 50314
        • Mercy Medical Center - Des Moines
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71103
        • LSU Health Sciences Center at Shreveport
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48106
        • Saint Joseph Mercy Hospital
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health at Butterworth Campus
      • Royal Oak, Michigan, Forenede Stater, 48073
        • William Beaumont Hospital-Royal Oak
    • Minnesota
      • Waconia, Minnesota, Forenede Stater, 55387
        • Ridgeview Medical Center
    • Missouri
      • Ballwin, Missouri, Forenede Stater, 63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Bolivar, Missouri, Forenede Stater, 65613
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, Forenede Stater, 65616
        • Cox Cancer Center Branson
      • Joplin, Missouri, Forenede Stater, 64804
        • Freeman Health System
      • Joplin, Missouri, Forenede Stater, 64804
        • Mercy Hospital Joplin
      • Rolla, Missouri, Forenede Stater, 65401
        • Delbert Day Cancer Institute at PCRMC
      • Rolla, Missouri, Forenede Stater, 65401
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Saint Louis, Missouri, Forenede Stater, 63131
        • Missouri Baptist Medical Center
      • Saint Louis, Missouri, Forenede Stater, 63141
        • Mercy Hospital Saint Louis
      • Saint Louis, Missouri, Forenede Stater, 63109
        • Saint Louis Cancer and Breast Institute-South City
      • Springfield, Missouri, Forenede Stater, 65807
        • CoxHealth South Hospital
      • Springfield, Missouri, Forenede Stater, 65804
        • Mercy Hospital Springfield
      • Washington, Missouri, Forenede Stater, 63090
        • Mercy Hospital Washington
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • University Medical Center of Southern Nevada
      • Reno, Nevada, Forenede Stater, 89503
        • Saint Mary's Regional Medical Center
    • New York
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center - Moses Campus
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Novant Health Forsyth Medical Center
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58122
        • Sanford Roger Maris Cancer Center
      • Fargo, North Dakota, Forenede Stater, 58103
        • Sanford South University Medical Center
    • Ohio
      • Chillicothe, Ohio, Forenede Stater, 45601
        • Adena Regional Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, Forenede Stater, 73120
        • Mercy Hospital Oklahoma City
    • Pennsylvania
      • Danville, Pennsylvania, Forenede Stater, 17822
        • Geisinger Medical Center
    • South Carolina
      • Boiling Springs, South Carolina, Forenede Stater, 29316
        • Prisma Health Cancer Institute - Spartanburg
      • Clinton, South Carolina, Forenede Stater, 29325
        • Prisma Health Cancer Institute - Laurens
      • Easley, South Carolina, Forenede Stater, 29640
        • Prisma Health Cancer Institute - Easley
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Faris
      • Greenville, South Carolina, Forenede Stater, 29615
        • Prisma Health Cancer Institute - Eastside
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Cancer Institute - Butternut
      • Greenville, South Carolina, Forenede Stater, 29605
        • Prisma Health Greenville Memorial Hospital
      • Greer, South Carolina, Forenede Stater, 29650
        • Prisma Health Cancer Institute - Greer
      • Seneca, South Carolina, Forenede Stater, 29672
        • Prisma Health Cancer Institute - Seneca
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38120
        • Baptist Memorial Hospital and Cancer Center-Memphis
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University/Massey Cancer Center
    • Wisconsin
      • La Crosse, Wisconsin, Forenede Stater, 54601
        • Gundersen Lutheran Medical Center
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Aurora Saint Luke's Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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 indgriben: 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)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Foranstaltningsbeskrivelse
Tidsramme
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.
6 months (after baseline)
Short-term Smoking Abstinence - Patient Survey
Tidsramme: 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.
3 months (after baseline)
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.
<= 14 days after baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Studiestol: Kristie Foley, PhD, Wake Forest University Health Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. juni 2018

Primær færdiggørelse (Faktiske)

22. februar 2021

Studieafslutning (Faktiske)

22. februar 2021

Datoer for studieregistrering

Først indsendt

19. september 2017

Først indsendt, der opfyldte QC-kriterier

19. september 2017

Først opslået (Faktiske)

25. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. juli 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2022

Sidst verificeret

1. juli 2022

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB00040071
  • 1R01CA207158-01 (U.S. NIH-bevilling/kontrakt)
  • REBAWF-20817CD (Anden identifikator: NCI)
  • NCI-2017-01669 (Registry Identifier: NCI CTRP)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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

IPD-delingsadgangskriterier

request using uniform resource locator (URL) below

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Personnel Training and Coaching Calls

3
Abonner