- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00712569
Physician-Patient Communication About Breast Cancer-Related Internet Information and Its Effect on Patient Satisfaction and Anxiety
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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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.
Prazo: 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).
Prazo: conclusion of study
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conclusion of study
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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To identify cancer patients' reasons for not discussing cancer-related internet information with their physicians. (Category 2 and 3 patients).
Prazo: conclusion of study
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conclusion of study
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 08-079
- NIH (Número de outro subsídio/financiamento: NIDA)
- NCI (HHSN261200700046C)
- R03CA130591-01 (Concessão/Contrato do NIH dos EUA)
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