- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07857681
Text Message and Mail Delivery of Tailored Educational Materials to Improve Access to Resources for Smoking Cessation of Menthol Tobacco Cigarettes
An Exploratory Investigation on Effectiveness of Tailored New York State Quitline Services for Cessation of Menthol Tobacco Cigarettes
This clinical trial compares the impact of receiving educational materials containing relevant content about risks from smoking menthol cigarettes which include links to the New York (NY) Smoke-Free website by text message or mail in people who smoke menthol cigarettes. The NY Smoke-Free website includes tailored content developed specifically for menthol smokers and provides resources designed to resonate with the experiences of menthol smokers and address the unique challenges they face in quitting. Delivering tailored educational materials by text message or mail may increase interaction with information about menthol cigarettes and smoking cessation resources compared to those who do not receive the educational messaging.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
PRIMARY OBJECTIVES:
I. Assess participant interaction with an educational message about menthol cigarettes by tracking visits to the Quitline website.
II. Assess participant interaction with the educational message delivered by text message with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web site.
III. Assess participant interaction with the educational message delivery by mail with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and quick response (QR) code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
GROUP II: Participants receive standard Quitline materials in the mail on study.
GROUP III: Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
Buffalo, New York, Estados Unidos, 14263
- Roswell Park Cancer Institute
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults aged 18 years or older
- Residents of New York State
- English Speaking
- Willingness to receive and engage with mailed educational materials
- Participants with ability to receive text messaging access to smart device
Exclusion Criteria:
- Report currently smoking menthol cigarettes
- People who do not report currently smoking menthol cigarettes
- Individuals under 18 years of age
- Persons in correctional facilities
- Non-English speaking
- Participants who cannot receive text messaging or have access to smart device
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Cohort II (standard Quitline materials)
Participants receive standard Quitline materials in the mail on study. |
Receive standard Quitline materials
Otros nombres:
|
|
Experimental: Group I (educational material by mail)
Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Receive standard Quitline materials
Otros nombres:
Receive an educational flyer by mail
Otros nombres:
Receive access to a website Receive access to a QR code
Otros nombres:
|
|
Experimental: Group III (educational messaging by text)
Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Receive standard Quitline materials
Otros nombres:
Receive access to a website Receive access to a QR code
Otros nombres:
Receive an educational message by text
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Engagement with quick response (QR) code scans
Periodo de tiempo: Up to 12 months
|
QR code will be scanned will be tracked through unique uniform resource locator assigned. Each scan will be documented, allowing for the counting of interactions (Poisson) directly affiliated with the materials distributed. Also, binary (yes/no) (Did the participant interact at least once). Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3). |
Up to 12 months
|
|
Website Utilization
Periodo de tiempo: Up to 12 months
|
total number of visits, unique visitors, |
Up to 12 months
|
|
Interactions with online resources
Periodo de tiempo: Up to 12 months
|
Interactions with online resources will include the number of clicks on website, and time spent on various pages. Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3). |
Up to 12 months
|
|
Website utilization
Periodo de tiempo: Up to 12 months
|
Duration of sessions |
Up to 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of website interactions from the mailed flyer
Periodo de tiempo: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of QR code interactions from the mailed flyer
Periodo de tiempo: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of website interactions from the text message
Periodo de tiempo: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Number of QR code interactions from the text message
Periodo de tiempo: Up to 12 months
|
Will measure participant engagement with the menthol educational materials. |
Up to 12 months
|
|
Duration spent on the cessation website
Periodo de tiempo: Up to 12 months
|
Will assess depth of engagement. |
Up to 12 months
|
|
Number of pages or resources accessed on the website
Periodo de tiempo: Up to 12 months
|
Will evaluate participant utilization of the content. |
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sarah Pearson-Collins, Roswell Park Cancer Institute
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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
Términos MeSH relevantes adicionales
- Técnicas de investigación
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Servicios de salud infantil
- Servicios de salud comunitarios
- Servicios de salud preventivos
- Factores socioeconómicos
- Características de la población
- Materiales manufacturados
- Tecnología, industria y agricultura
- Métodos
- Intervención temprana, educativa
- Estado educativo
- Dispositivos para fumar
Otros números de identificación del estudio
- I-4464925
- NCI-2025-03221 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- I-4464925 (Otro identificador: Roswell Park Cancer Institute)
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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