Communicating Objective Risk for Personalized Decision Making About Mammography
20 de julio de 2017 actualizado por: University of Pennsylvania
The purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial.
Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths.
Two presentation formats will be tested and compared.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.
After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.
After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.
In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1560
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
35 años a 49 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Adult women between the ages of 35 and 49 will be invited to participate in this study.
Exclusion Criteria:
- Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control group 1: pre/post-test
Group receives pre and post test questions only.
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Experimental: Control group 2: tool and pre/post-test
Group receives decision tool without personalized information.
(Behavioral: Decision Aid)
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Experimental: Gail score in a percentage format
Group receives Gail score in a percentage format.
(Behavioral: Decision Aid)
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Experimental: Gail score in a frequency format
Group receives Gail score in a frequency format.
(Behavioral: Decision Aid)
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Experimental: Frequency + Average 50 year old
Group receives Gail score in a frequency format as well as information about risk of breast cancer for the average 50 year old woman.
(Behavioral: Decision Aid)
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Experimental: Frequency + Mammography Data
Group receives Gail score in a frequency format as well as information about the risks of mammography.
(Behavioral: Decision Aid)
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Experimental: Frequency + Mortality Data
Group receives Gail score in a frequency format as well as information about mortality benefit of mammography.
(Behavioral:Decision Aid)
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Experimental: Frequency + Avg 50 year old + Mamm Data + Mortality Data
Group receives Gail score in a frequency format as well as information about breast cancer risk for the average 50 year old woman, information about the risks of mammography, risk of breast cancer for the average 50 year old woman, and information about the mortality benefit associated with mammography.
(Behavioral: Decision Aid)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Behavioral intentions to get a mammogram
Periodo de tiempo: immediately following intervention (time 0)
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All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.
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immediately following intervention (time 0)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Attitude about mammography
Periodo de tiempo: immediately following intervention (time 0)
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Participants will be asked to report their attitudes about mammography (i.e., is a mammogram useful, harmful, etc.)
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immediately following intervention (time 0)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Injunctive and descriptive norms about mammography
Periodo de tiempo: immediately following intervention (time 0)
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Participants will be asked to report their perceived norms about mammography, what they think important others would expect them to do and what they think other women their age or older are doing.
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immediately following intervention (time 0)
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Decisional satisfaction
Periodo de tiempo: immediately following intervention (time 0)
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This variable assesses how satisfied participants feel about making a decision about mammography given the information they have been provided.
Items include, "The information in the decision aid made me feel the choice to get a mammogram is being taken away from me by the groups that make screening recommendations."
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immediately following intervention (time 0)
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Risk perception
Periodo de tiempo: immediately before and after intervention (time 0)
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This variable includes perceived severity and perceived susceptibility of breast cancer.
Items include, "What is the chance that an average 40-49 year old woman will develop breast cancer in the next 10 years?
Please choose a number between 0 (no chance of breast cancer) and 100 (definitely will get breast cancer)."
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immediately before and after intervention (time 0)
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Clarity of the information being presented
Periodo de tiempo: immediately following intervention (time 0)
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These items assess how easy it is for participants to understand the numerical information that is provided in the decision aid.
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immediately following intervention (time 0)
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Credibility of the information
Periodo de tiempo: immediately following intervention (time 0)
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These items measure the perceived trustworthiness, credibility, and accuracy of the information provided in the decision aid.
Items include, "How credible did you find the information presented in the decision aid?"
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immediately following intervention (time 0)
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Emotional reactions
Periodo de tiempo: immediately following intervention (time 0)
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The outcome includes measures of psychological reactance, anger, and fear that may be possible reactions to the decision aid.
Items include, "How much do each of the following words (i.e., angry, worried) describe how you felt while reading the decision aid?"
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immediately following intervention (time 0)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Joseph N Cappella, PhD, University of Pennsylvania
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2012
Finalización primaria (Actual)
18 de diciembre de 2012
Finalización del estudio (Actual)
18 de diciembre de 2012
Fechas de registro del estudio
Enviado por primera vez
28 de agosto de 2012
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2012
Publicado por primera vez (Estimar)
18 de septiembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de julio de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
20 de julio de 2017
Última verificación
1 de julio de 2017
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 816186
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. .