- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07802054
Messages That Motivate: Communicating Alcohol-Related Breast Cancer Risk to Young Adult Women (MEMO)
Descripción general del estudio
Estado
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: The Ohio State University Comprehensive Cancer Center
- Número de teléfono: 800-293-5066
- Correo electrónico: OSUCCCClinicaltrials@osumc.edu
Ubicaciones de estudio
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University Comprehensive Cancer Center
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Investigador principal:
- Darren Mays, MPH, PhD
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Contacto:
- Darren Mays, MPH, PhD
- Número de teléfono: 614-366-2953
- Correo electrónico: Darren.Mays@osumc.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Assigned female at birth
- Age 18-25
- Report drinking alcohol at least once in the past 30 days
- Registered in the United States as a member of the Prolific consumer research platform
- Willing and able to complete procedures in English
Exclusion Criteria:
- Assigned male at birth
- Ages <18 or >25
- Do not report drinking alcohol at least once in the past 30 days
- Not registered in the U.S. as a member of the Prolific consumer research platform
- Not willing or not able to complete procedures
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 |
|---|---|
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Experimental: Arm 1: Risk Only + Industry Deception
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Risk message content
Messages with information about alcohol industry deception
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Experimental: Arm 2: Risk Only + YAW Susceptibility
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Risk message content
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
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Experimental: Arm 3: Risk Only + Mechanisms
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Risk message content
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
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Experimental: Arm 4: Efficacy Only + Industry Deception
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Messages with information about alcohol industry deception
Efficacy Message Content
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Experimental: Arm 5: Efficacy Only + YAW Susceptibility
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Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
Efficacy Message Content
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Experimental: Arm 6: Efficacy Only + Mechanisms
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Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
Efficacy Message Content
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Experimental: Arm 7: Risk and Efficacy + Industry Deception
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Risk message content
Messages with information about alcohol industry deception
Efficacy Message Content
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Experimental: Arm 8: Risk and Efficacy + YAW Susceptibility
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Risk message content
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
Efficacy Message Content
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Experimental: Arm 9: Risk and Efficacy + Mechanisms
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Risk message content
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
Efficacy Message Content
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Message Perceptions
Periodo de tiempo: This assessment is administered immediately after participants view study messages on Day 1
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We will assess message perceptions using a valid, reliable measure with six questions about whether participants thought the messages were worth remembering, grabbed their attention, and were informative, powerful, convincing, and meaningful. Responses are on a five-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean. Higher values are considered a better outcome. |
This assessment is administered immediately after participants view study messages on Day 1
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Effect Perceptions
Periodo de tiempo: This assessment is administered immediately after participants view study messages on Day 1
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We will capture message effects perceptions using the abbreviated effects perceptions scale.
Items include questions about how much the messages made them feel discouraged to drink alcohol, concerned about drinking alcohol, and made them feel that drinking alcohol is unpleasant on a scale from 1 (Strongly disagree) to 5 (Strongly agree).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
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This assessment is administered immediately after participants view study messages on Day 1
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Emotional Response
Periodo de tiempo: This assessment is administered immediately after participants view study messages on Day 1
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We will capture emotional responses to the messages using a valid, four item scale.
Items are "This message made me angry; irritated; aggravated; and annoyed" with responses on a 5-point Likert scale from 1 (Not likely at all) to 5 (Extremely likely).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
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This assessment is administered immediately after participants view study messages on Day 1
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Counter-arguing
Periodo de tiempo: This assessment is administered immediately after participants view study messages on Day 1
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We will capture counter-arguing, a measure of whether participants cognitively refute messages, with a valid, three item scale that captures whether participants criticize messages, think of points that go against messages, and are skeptical of the messages.
Responses are on a 5-point Likert scale ranging from 1 (Not at all) to 7 (Very much).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Lower values are considered a better outcome.
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This assessment is administered immediately after participants view study messages on Day 1
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Behavioral Intentions
Periodo de tiempo: This assessment is administered immediately after participants view study messages on Day 1
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Intentions to reduce alcohol consumption in the future will also be assessed with a valid, multi-item scale capturing whether participants will avoid drinking alcohol completely, reduce the number of occasions when they drink alcohol, and reduce the amount of alcohol they consume on drinking occasions with a 1 (Definitely Will Not) to 4 (Definitely Will) response scale.
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Darren Mays, MPH, PhD, The Ohio State University Comprehensive Cancer Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Otros números de identificación del estudio
- OSU-26048
- R01CA311193-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .