Implementation of Smoking Cessation Within NCI Community Oncology Research Program (NCORP) Sites (OaSiS)
20 июля 2022 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
1094
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Delaware
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Newark, Delaware, Соединенные Штаты, 19713
- Helen F Graham Cancer Center
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Georgia
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Augusta, Georgia, Соединенные Штаты, 30912
- Augusta University Medical Center
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Savannah, Georgia, Соединенные Штаты, 31405
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
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Hawaii
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Honolulu, Hawaii, Соединенные Штаты, 96859
- Tripler Army Medical Center
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Illinois
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Mount Vernon, Illinois, Соединенные Штаты, 62864
- Good Samaritan Regional Health Center
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Urbana, Illinois, Соединенные Штаты, 61801
- Carle Cancer Center
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Iowa
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Ames, Iowa, Соединенные Штаты, 50010
- McFarland Clinic PC - Ames
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Des Moines, Iowa, Соединенные Штаты, 50314
- Mercy Medical Center - Des Moines
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Louisiana
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Shreveport, Louisiana, Соединенные Штаты, 71103
- LSU Health Sciences Center at Shreveport
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Michigan
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Ann Arbor, Michigan, Соединенные Штаты, 48106
- Saint Joseph Mercy Hospital
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Grand Rapids, Michigan, Соединенные Штаты, 49503
- Spectrum Health at Butterworth Campus
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Royal Oak, Michigan, Соединенные Штаты, 48073
- William Beaumont Hospital-Royal Oak
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Minnesota
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Waconia, Minnesota, Соединенные Штаты, 55387
- Ridgeview Medical Center
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Missouri
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Ballwin, Missouri, Соединенные Штаты, 63011
- Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar, Missouri, Соединенные Штаты, 65613
- Central Care Cancer Center - Bolivar
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Branson, Missouri, Соединенные Штаты, 65616
- Cox Cancer Center Branson
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Joplin, Missouri, Соединенные Штаты, 64804
- Freeman Health System
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Joplin, Missouri, Соединенные Штаты, 64804
- Mercy Hospital Joplin
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Rolla, Missouri, Соединенные Штаты, 65401
- Delbert Day Cancer Institute at PCRMC
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Rolla, Missouri, Соединенные Штаты, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
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Saint Louis, Missouri, Соединенные Штаты, 63131
- Missouri Baptist Medical Center
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Saint Louis, Missouri, Соединенные Штаты, 63141
- Mercy Hospital Saint Louis
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Saint Louis, Missouri, Соединенные Штаты, 63109
- Saint Louis Cancer and Breast Institute-South City
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Springfield, Missouri, Соединенные Штаты, 65807
- CoxHealth South Hospital
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Springfield, Missouri, Соединенные Штаты, 65804
- Mercy Hospital Springfield
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Washington, Missouri, Соединенные Штаты, 63090
- Mercy Hospital Washington
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Nevada
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Las Vegas, Nevada, Соединенные Штаты, 89102
- University Medical Center of Southern Nevada
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Reno, Nevada, Соединенные Штаты, 89503
- Saint Mary's Regional Medical Center
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New York
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Bronx, New York, Соединенные Штаты, 10467
- Montefiore Medical Center - Moses Campus
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North Carolina
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Winston-Salem, North Carolina, Соединенные Штаты, 27103
- Novant Health Forsyth Medical Center
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North Dakota
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Fargo, North Dakota, Соединенные Штаты, 58122
- Sanford Roger Maris Cancer Center
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Fargo, North Dakota, Соединенные Штаты, 58103
- Sanford South University Medical Center
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Ohio
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Chillicothe, Ohio, Соединенные Штаты, 45601
- Adena Regional Medical Center
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73120
- Mercy Hospital Oklahoma City
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Pennsylvania
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Danville, Pennsylvania, Соединенные Штаты, 17822
- Geisinger Medical Center
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South Carolina
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Boiling Springs, South Carolina, Соединенные Штаты, 29316
- Prisma Health Cancer Institute - Spartanburg
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Clinton, South Carolina, Соединенные Штаты, 29325
- Prisma Health Cancer Institute - Laurens
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Easley, South Carolina, Соединенные Штаты, 29640
- Prisma Health Cancer Institute - Easley
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Greenville, South Carolina, Соединенные Штаты, 29605
- Prisma Health Cancer Institute - Faris
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Greenville, South Carolina, Соединенные Штаты, 29615
- Prisma Health Cancer Institute - Eastside
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Greenville, South Carolina, Соединенные Штаты, 29605
- Prisma Health Cancer Institute - Butternut
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Greenville, South Carolina, Соединенные Штаты, 29605
- Prisma Health Greenville Memorial Hospital
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Greer, South Carolina, Соединенные Штаты, 29650
- Prisma Health Cancer Institute - Greer
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Seneca, South Carolina, Соединенные Штаты, 29672
- Prisma Health Cancer Institute - Seneca
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Tennessee
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Memphis, Tennessee, Соединенные Штаты, 38120
- Baptist Memorial Hospital and Cancer Center-Memphis
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Virginia
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Richmond, Virginia, Соединенные Штаты, 23235
- VCU Massey Cancer Center at Stony Point
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Richmond, Virginia, Соединенные Штаты, 23298
- Virginia Commonwealth University/Massey Cancer Center
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Wisconsin
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La Crosse, Wisconsin, Соединенные Штаты, 54601
- Gundersen Lutheran Medical Center
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Milwaukee, Wisconsin, Соединенные Штаты, 53215
- Aurora Saint Luke's Medical Center
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
18 лет и старше (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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. |
|
Без вмешательства: 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) |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Percentage of Patients With 7-day Sustained Smoking Abstinence Reported in the Patient Survey
Временное ограничение: 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)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Salivary Cotinine Test for Non-Smokers
Временное ограничение: 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)
|
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Short-term Smoking Abstinence - Patient Survey
Временное ограничение: 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)
|
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Total Number of Services Participant Reported Received at 14 Days
Временное ограничение: <= 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
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Учебный стул: Kristie Foley, PhD, Wake Forest University Health Sciences
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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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.
- D'Agostino RB, Rubin DB. Estimating and Using Propensity Scores with Partially Missing Data. J Am Stat Assoc. 2000;95(451):749-759. doi:10.2307/2669455.
- D'Agostino RB Jr, D'Agostino RB Sr. Estimating treatment effects using observational data. JAMA. 2007 Jan 17;297(3):314-6. doi: 10.1001/jama.297.3.314. No abstract available.
Полезные ссылки
- 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
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 июня 2018 г.
Первичное завершение (Действительный)
22 февраля 2021 г.
Завершение исследования (Действительный)
22 февраля 2021 г.
Даты регистрации исследования
Первый отправленный
19 сентября 2017 г.
Впервые представлено, что соответствует критериям контроля качества
19 сентября 2017 г.
Первый опубликованный (Действительный)
25 сентября 2017 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
25 июля 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
20 июля 2022 г.
Последняя проверка
1 июля 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- IRB00040071
- 1R01CA207158-01 (Грант/контракт NIH США)
- REBAWF-20817CD (Другой идентификатор: NCI)
- NCI-2017-01669 (Идентификатор реестра: NCI CTRP)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена IPD
see NIH policy
Критерии совместного доступа к IPD
request using uniform resource locator (URL) below
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
Клинические исследования Personnel Training and Coaching Calls
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Unity Health TorontoOCAD University; Toronto Public HealthЗавершенный