Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)
20 de julho de 2022 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
1094
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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. |
|
Sem intervenção: 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) |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Salivary Cotinine Test for Non-Smokers
Prazo: 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
Prazo: 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
Prazo: <= 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Kristie Foley, PhD, Wake Forest University Health Sciences
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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Links úteis
- Medicare Coverage Database - Centers for Medicare & Medicaid Services
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de junho de 2018
Conclusão Primária (Real)
22 de fevereiro de 2021
Conclusão do estudo (Real)
22 de fevereiro de 2021
Datas de inscrição no estudo
Enviado pela primeira vez
19 de setembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de setembro de 2017
Primeira postagem (Real)
25 de setembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de julho de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de julho de 2022
Última verificação
1 de julho de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- IRB00040071
- 1R01CA207158-01 (Concessão/Contrato do NIH dos EUA)
- REBAWF-20817CD (Outro identificador: NCI)
- NCI-2017-01669 (Identificador de registro: NCI CTRP)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
see NIH policy
Critérios de acesso de compartilhamento IPD
request using uniform resource locator (URL) below
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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