- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07681791
Sun Safe Together: A Digital Skin Cancer Prevention Intervention for Adolescents and Their Parents
A Digital Skin Cancer Prevention Intervention for Adolescents and Their Parents
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Melanoma is a leading cause of invasive cancer in teens and young adults aged 15-39. Most skin cancers are preventable with skin protection such as minimizing UVR exposure and wearing protective clothing and sunscreen. However, teens have low levels of sun protection. Thus, interventions targeting skin cancer risk reduction among teens are needed. The proposed Sun Safe Together (SST) intervention is a 12-week program consisting of sun safety and general health messages sent via multimedia messaging service (MMS) to teens and via a private Facebook group for parents.
This pilot trial is a single arm test of SST to determine:
- feasibility of enrolling parent-teen dyads
- engagement with/acceptability of the intervention via message views and acceptability ratings
- outcome data collection feasibility (i.e., daily diary, UVR exposure measured by UVR dosimeter)
- retention rates for teens and parents at 3 and 6 months
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Reclutamiento
- Rutgers Cancer Institute
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Contacto:
- Anna Mitarotondo, MS
- Número de teléfono: 732-514-2891
- Correo electrónico: atm122@cinj.rutgers.edu
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Contacto:
- Carolyn J. Heckman, PhD
- Correo electrónico: teenhealthstudy@cinj.rutgers.edu
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Investigador principal:
- Carolyn J. Heckman, PhD
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Investigador principal:
- Katie A. Devine, PhD, MPH
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Parents and teens are participating as dyads, meaning both the parent and the teen need to be deemed eligible based on the criteria below to be able to participate.
Teens
- Must be ages 13-17 years
- Live with study parent equal to or greater than half time in US
- Have experienced sunburn or indoor tanned in the last year or have a suboptimal sun protection score
- Have no personal history of melanoma or severe medical condition that prevents participation
- Have access to smartphone
- Speak and read English
Parents/Guardians
- Must be age 18 or older
- Live with a teen equal to or greater than half time in US
- Have a teen who had experienced sunburn or indoor tanned in the last year or have a suboptimal sun protection score
- Have no personal history of melanoma or severe medical condition that prevents participation
- Have internet at home, a Facebook account, and be willing to use Facebook daily
- Have access to smartphone
- Speak and read English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Teen MMS & Parent Facebook Intervention
|
Teens will receive MMS messages regarding sun safety behaviors and other general health issues for 12 weeks.
Parents of teenagers join a private Facebook group where membership, activities, and content are only viewable by invited members.
Content related to teen sun safety and general health will be posted for 12 weeks.
Research staff will moderate the group.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility of recruitment
Periodo de tiempo: Baseline
|
Feasibility of recruitment will be assessed by the proportion of eligible parent-teen dyads that enroll in the study
|
Baseline
|
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Acceptability of MMS intervention
Periodo de tiempo: Immediately after the intervention
|
Items were adapted from the Acceptability of Intervention and Feasibility of Intervention Measures to obtain participant feedback about the acceptability, feasibility, ease of use, and impact of the intervention.
Individual items are rated on a 5-point likert scale from (1) Completely Disagree to (5) Completely Agree.
Higher scores indicated greater acceptability.
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Immediately after the intervention
|
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Engagement with MMS intervention
Periodo de tiempo: 3-months
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Proportion of messages viewed will be calculated to describe engagement.
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3-months
|
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Feasibility of Outcome Data Collection - 7-Day Diaries
Periodo de tiempo: Baseline, 3-months, 6-months
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Proportion of teens who complete 7-day diaries will be calculated.
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Baseline, 3-months, 6-months
|
|
Feasibility of Outcome Data Collection - UVR Dosimeter
Periodo de tiempo: Baseline, 6 months
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Proportion of teens who return UVR dosimeter with usable data will be calculated.
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Baseline, 6 months
|
|
Retention
Periodo de tiempo: 3-months, 6-months
|
Proportion of enrolled teens who complete surveys at 3- and 6-months will be calculated.
|
3-months, 6-months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carolyn Heckman, PhD, Rutgers, The State University of New Jersey
- Investigador principal: Katie A Devine, PhD, Rutgers, The State University of New Jersey
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
Otros números de identificación del estudio
- Pro2025001264
- R34CA293237 (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.
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