Implementación del tratamiento del tabaquismo en sitios de detección de cáncer de pulmón con TC de dosis baja
This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90033
- University of Southern California (Data Collection Only)
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Walnut Creek, California, Estados Unidos, 94598
- John Muir Health
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Georgia
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La Grange, Georgia, Estados Unidos, 30240
- WellStar Health System
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Illinois
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Chicago, Illinois, Estados Unidos, 606012
- Rush University Medical Center
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Kankakee, Illinois, Estados Unidos, 60901
- Riverside Healthcare
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Indiana
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Crown Point, Indiana, Estados Unidos, 46307
- St. Mary Medical Center, Community Healthcare System
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Iowa
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Des Moines, Iowa, Estados Unidos, 50314
- MercyOne Des Moines Medical Center (Data Collection Only)
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Maine
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Scarborough, Maine, Estados Unidos, 04074
- Maine Medical Center Cancer Institute
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Henry Ford Hospital (Data collection only)
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Traverse City, Michigan, Estados Unidos, 49684
- Munson Healthcare
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New York
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Mineola, New York, Estados Unidos, 11501
- NYU Winthrop Hospital
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New York, New York, Estados Unidos, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, Estados Unidos, 10065
- Weill Cornell Medical Center
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The Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center (Data Collection Only)
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North Carolina
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Morganton, North Carolina, Estados Unidos, 28655
- Carolinas Healthcare System Blue Ridge
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Ohio
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Lancaster, Ohio, Estados Unidos, 43130
- Fairfield Medical Center
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Oregon
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Portland, Oregon, Estados Unidos, 97210
- Legacy Health
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Site Eligibility (as per SC self-report)
& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site
- Reports at least one year of lung cancer screening experience
- Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)
- Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)
- Between the ages of 50-80 years old
- Seeking baseline or annual follow-up LDCT lung cancer screening
- Have at least a 20 pack-year history of smoking
- Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.
- Must be reachable by telephone
- Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.
Exclusion Criteria:
Patient (as per self-report)
- NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).
- Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Motivational Interviewing( MI) (Yes vs. No)
Participants will receive two motivational informed cessation sessions; the first delivered face to faceor via telephone by the SC during the patient's initial lung cancer screening visit or during the shared decision making discussion or within about 1 week following their screening visit, and the second session delivered by telephone by the SC approximately 4 to 8 weeks after the first MI session. |
two counseling sessions saliva samples from those reporting abstinence and analyze samples |
|
Experimental: Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)
Participants will receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day and written instructions to use the patch daily starting on date they mutually agreed upon with their site coordinator. Participants who smoke fewer than 10 cigarettes per day will receive 4-weeks of the 14mg patch (2 boxes), and 2-weeks of the 7mg patch (1 box). Those who smoke 10 or more cigarettes per day will receive 4-weeks of the 21mg patch (2 boxes) and 2-weeks of the 14mg patch (1 box). Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion & Fulfillment. |
saliva samples from those reporting abstinence and analyze samples receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day |
|
Experimental: NRT Lozenge (Yes vs. No)
Participants will receive will receive 6 packs of NRT 2mg lozenge and written instructions to use the lozenge PRN to help manage acute nicotine withdrawal. Participants will be instructed to use the NRT lozenges no more than every 1-2 hours as needed. Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion & Fulfillment. |
saliva samples from those reporting abstinence and analyze samples 6 packs of NRT 2mg lozenge |
|
Experimental: Message Framing (Gain vs. Loss)
Overall, a robust body of health communication literature demonstrates that gain-framed messages may be more effective than loss-framed or non-framed (neutral) messages for encouraging smoking cessation. In other words, quitting messages that promote smoking cessation are more persuasive if they emphasize the benefits of quitting (gain-framed) rather than the risks (loss-framed) of persistent smoking (25, 26). Included with the written communication of their LDCT-LCS results, participants will receive a printed individualized quitting message that emphasizes either the benefits of quitting (gain-framed) or the risks of continuing to smoke (loss-framed). |
saliva samples from those reporting abstinence and analyze samples health communication literature and quitting messages |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
number of patients who are tobacco abstinence
Periodo de tiempo: 6 months following study enrollment
|
biochemical verification of smoking abstinence will be conducted Consistent with Intent to Treat, unless self reported smoking abstinence is biochemically verified, (<3 ng/ml for mailed salivary cotinine assay) for participants who fail to return the saliva sample, the cessation outcome will be considered non-abstinent. |
6 months following study enrollment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jamie Ostroff, PhD, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Comportamiento
- Comportamiento de salud
- Dejar de fumar
- Terapéutica
- Terapia con drogas
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Disciplinas y actividades de comportamiento
- Asesoramiento directivo
- Asesoramiento
- Servicios de salud mental
- Entrevistas motivacionales
- Tobacco Use dispositivos de cesación
- Terapia de reemplazo de nicotina
Otros números de identificación del estudio
- 17-500
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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