- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02147080
A Tailored Internet Intervention to Reduce Skin Cancer Risk Behaviors Among Young Adults (UV4me)
Skin cancer is the most common cancer in the US, with over a million new cases diagnosed yearly. Young adults are increasingly at risk of melanoma. Contributing to the increasing skin cancer risk is the fact that US adolescents have the lowest skin protection rates of all age groups and also demonstrate increased exposure to natural and artificial UV radiation. Innovative interventions are needed to have an impact on skin cancer risk among young people. Unlike previous interventions, our skin cancer risk reduction intervention will be tailored (or personalized) to each individual participant and delivered via the Internet. The intervention will emphasize appearance concerns, which are known to be the primary motivation for UV exposure and lack of skin protection among young adults. This will be accomplished in part through the use of personalized facial images showing UV damage as well as computerized age progression demonstrations.
Primary Aim 1. To examine the efficacy of a tailored intervention delivered via the Internet designed to increase skin protection and decrease sun exposure behavior among young adults at moderate to high risk of developing skin cancer. Participants will be randomized to the tailored intervention, the Skin Cancer Foundation website, or an assessment only condition.
Aim 2. To evaluate whether sociodemographic variables (sex, race/ethnicity, skin type, family history of skin cancer), appearance consciousness, and past exposure and protective behaviors moderate intervention effects.
Aim 3. To evaluate whether Integrative Model constructs (UV-related knowledge, risk perception, beliefs, norms, self-efficacy, and intentions) mediate intervention effects.
The goals of future research would be to enhance the tailored intervention, for example, by adding additional contacts or Internet technologies or features, disseminate the intervention, assess the longevity of effects, and/or adapt the tailored intervention for use with other cancer risk behaviors or at risk groups.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19111
- Fox Chase Cancer Center
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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:
- Age 18-25 years old
- Moderate to high risk of skin cancer (cut-off of >=27 on the Brief Skin Cancer Risk Assessment Tool)
Exclusion Criteria:
- History of skin cancer
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Tailored Intervention
Subject has access to the tailored web intervention
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Tailored website includes: personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individual, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator
Otros nombres:
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Comparador activo: Skin Cancer Foundation Website
Subject has access to the pre-existing Skin Cancer Foundation website
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Current best practice website for skin cancer and prevention.
Includes information, images, news, and opportunities for advocacy.
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Sin intervención: Assessment Only Condition
Subjects will only complete assessments
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Sun protection
Periodo de tiempo: Follow-up 1 (3 weeks after baseline)
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Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
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Follow-up 1 (3 weeks after baseline)
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Sun protection
Periodo de tiempo: Follow-up 2 (12 weeks after baseline)
|
Continuous measure examining frequency of sun protection behaviors (e.g., sunscreen use, clothing, shade, sunglasses), using items adapted from Glanz and colleagues (2008)
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Follow-up 2 (12 weeks after baseline)
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Outdoor UV Exposure
Periodo de tiempo: Follow-up 1 (3 weeks after baseline)
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How many hours participants spend in the sun during peak daylight hours during the week
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Follow-up 1 (3 weeks after baseline)
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Outdoor UV exposure
Periodo de tiempo: Follow-up 2 (12 weeks after baseline)
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How many hours participants spend in the sun during peak daylight hours during the week
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Follow-up 2 (12 weeks after baseline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Indoor Tanning
Periodo de tiempo: Follow-up 1 (3 weeks after baseline)
|
Number of indoor tanning sessions in past month
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Follow-up 1 (3 weeks after baseline)
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Indoor Tanning
Periodo de tiempo: Follow-up 2 (12 weeks after baseline)
|
Number of indoor tanning sessions in past month
|
Follow-up 2 (12 weeks after baseline)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Spray-on tan
Periodo de tiempo: Follow-up 1 (3 weeks after baseline)
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Number of spray-on tanning sessions in past month
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Follow-up 1 (3 weeks after baseline)
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Spray-on tan
Periodo de tiempo: Follow-up 2 (12 weeks after baseline)
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Number of spray-on tanning sessions in past month
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Follow-up 2 (12 weeks after baseline)
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Sunless tanning creams
Periodo de tiempo: Follow-up 1 (3 weeks after baseline)
|
Number of times sunless tanning cream has been used in the past month
|
Follow-up 1 (3 weeks after baseline)
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Sunless tanning creams
Periodo de tiempo: Follow-up 2 (12 weeks after baseline)
|
Number of times sunless tanning cream has been used in the past month
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Follow-up 2 (12 weeks after baseline)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Carolyn Heckman, Ph.D, Fox Chase Cancer Center
Publicaciones y enlaces útiles
Publicaciones Generales
- Heckman CJ, Handorf EA, Darlow SD, Ritterband LM, Manne SL. An online skin cancer risk-reduction intervention for young adults: Mechanisms of effects. Health Psychol. 2017 Mar;36(3):215-225. doi: 10.1037/hea0000420. Epub 2016 Nov 7.
- Heckman CJ, Darlow SD, Ritterband LM, Handorf EA, Manne SL. Efficacy of an Intervention to Alter Skin Cancer Risk Behaviors in Young Adults. Am J Prev Med. 2016 Jul;51(1):1-11. doi: 10.1016/j.amepre.2015.11.008. Epub 2016 Jan 22.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
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
- 1R01CA154928-01 (Subvención/contrato del NIH de EE. UU.)
- 1R01CA154928 (Subvención/contrato del NIH de EE. UU.)
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