Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

20 juli 2022 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

1094

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Inget ingripande: 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)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Salivary Cotinine Test for Non-Smokers
Tidsram: 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
Tidsram: 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
Tidsram: <= 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juni 2018

Primärt slutförande (Faktisk)

22 februari 2021

Avslutad studie (Faktisk)

22 februari 2021

Studieregistreringsdatum

Först inskickad

19 september 2017

Först inskickad som uppfyllde QC-kriterierna

19 september 2017

Första postat (Faktisk)

25 september 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 juli 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

20 juli 2022

Senast verifierad

1 juli 2022

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • IRB00040071
  • 1R01CA207158-01 (U.S.S. NIH-anslag/kontrakt)
  • REBAWF-20817CD (Annan identifierare: NCI)
  • NCI-2017-01669 (Registeridentifierare: NCI CTRP)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

see NIH policy

Kriterier för IPD Sharing Access

request using uniform resource locator (URL) below

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Personnel Training and Coaching Calls

Prenumerera