- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00712569
Physician-Patient Communication About Breast Cancer-Related Internet Information and Its Effect on Patient Satisfaction and Anxiety
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Commack, New York, Estados Unidos
- Memorial Sloan-Kettering Cancer Center at Commack
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New York, New York, Estados Unidos, 10065
- Memorial Sloan-Kettering Cancer Center
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Sleepy Hollow, New York, Estados Unidos
- Memoral Sloan Kettering Cancer Center@Phelps
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
Subject Inclusion Criteria for Patients
- Female
- Diagnosis of breast cancer
- Pre-surgery (*for breast surgeon patients only)
- Report that they have read breast cancer-related internet information since their diagnosis with breast cancer.
- Provide informed consent
Subject Inclusion Criteria Physicians
- Breast surgeon or breast medical oncologist
- Agree to participate in study and one of 10 selected participants
- Provide inform consent
Exclusion Criteria:
Exclusion Criteria for Patients
- Less than 21 years of age
- Cognitive or physical impairment rendering patients incapable of providing informed consent to participate in the study
- As the measures and coding system are all written in English, subjects who are not fluent in English will be excluded.
Exclusion Criteria for Physicians
- None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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1
Patients in Category 1 are those who report before the visit that they intend to discuss cancer-related internet information and report after the visit that they did discuss such information.
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Patients in Category 1 are those who report before the visit that they intend to discuss cancer-related internet information and report after the visit that they did discuss such information.
The coding of these patients' consultations with their physicians and analysis of their pre- and post-consultation questionnaires will address Aims 1 and 2.
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2
Patients in Category 2 are those who report before the visit that they intend to discuss cancer-related internet information, but report after the visit that they did not discuss such information.
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Patients in Category 2 are those who report before the visit that they intend to discuss cancer-related internet information, but report after the visit that they did not discuss such information. This category is important as our previous research indicates that sometimes patients do not discuss information because they feel there is not enough time or because the information is irrelevant or repetitive. These patients' audio recordings will be checked to verify that there was no internet information discussion. These audio recordings will not be coded. However, assessment of these patients' questionnaires will aid in addressing Aim 3 and may provide some pilot data on why patients who initially intend to discuss internet information do not. |
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3
Patients in Category 3 are those who report before the visit that they do not intend to discuss cancer-related internet information and do not discuss it.
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Patients in Category 3 are those who report before the visit that they do not intend to discuss cancer-related internet information and do not discuss it.
Assessment of these patients' questionnaires will aid in addressing Aim 3.
These audio recordings will not be coded.
It is important, however, that these consultations be audio recorded for two reasons: First, it allows the physician to remain blinded to the intent of the patient to discuss internet information.
Second, it provides a method of verifying that the patient really did not discuss internet information.
Although not expected, it is possible for a patient to go into a consultation without intending to discuss internet information, but does end up discussing it.
We will note if this occurs.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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patients in Category 1 (those who have been recorded discussing internet information with their physician) are pt satisfaction & pt anxiety. PT satisfaction with the consultation is an outcome assessed only at the end of the consultation.
Periodo de tiempo: conclusion of the study
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conclusion of the study
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To examine the effect of physician responses to cancer-related internet information on patient satisfaction and anxiety. (Category 1 patients).
Periodo de tiempo: conclusion of study
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conclusion of study
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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To identify cancer patients' reasons for not discussing cancer-related internet information with their physicians. (Category 2 and 3 patients).
Periodo de tiempo: conclusion of study
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conclusion of study
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
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 (Estimar)
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
- 08-079
- NIH (Otro número de subvención/financiamiento: NIDA)
- NCI (HHSN261200700046C)
- R03CA130591-01 (Subvención/contrato del NIH de EE. UU.)
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