- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02147106
Use of Video Consultation in Follow-up Care for Patients With a Neuroendocrine Tumor: a Feasibility Study (VIDEO-NET)
Use of Video Consultation in Follow-up Care for Patients With a NeuroEndocrine Tumor: a Feasibility Study (VIDEO-NET Study)
Rationale: Patients with neuroendocrine tumors (NET) have a rare disease. Due to treating patients with a neuroendocrine tumor in 'NET knowledge centers' patients often have to travel long distances for follow-up visits at the outpatient clinic. Patients whose medical condition allows videoconsultation could save time by replacing outpatient clinic visits through videoconsultation for receiving follow-up care. Therefore, in this study we aim to introduce videoconsultation as a alternative for follow-up outpatient clinic visits in NET patients.
Objective: The primary objective is to assess if use of videoconsultation in follow-up care for NET patients is feasible. We hypothesize that videoconsultation is a suitable medium for providing follow-up care in NET patients. Secondary objectives are to explore the amount of time videoconsultation takes in comparison with outpatient clinic visits and the acceptability and satisfaction of physicians and patients with using videoconsultation in follow-up care.
Study design: The present study is a single-centre prospective feasibility study.
Study population: Adult NET patients under surveillance or treatment of the department Medical Oncology at the University Medical Centre Groningen (UMCG) whose medical condition allows videoconsultation will be invited to participate.
Intervention: Patient who give informed consent will participate in the study. Participants will receive follow-up care through videoconsultation instead of conventional visits at the outpatient clinic.
Main study parameters/endpoints: The main endpoint is the feasibility of videoconsultation for follow-up care in NET patients. We hypothesize that videoconsultation is a suitable medium for providing follow-up care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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-
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Groningen, Países Bajos, 9713 GZ
- University Medical Center Groningen
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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:
- Signed informed consent
- Age ≥ 18 yrs
- Grade I or II (low and intermediate grade) NET with any primary tumor type or disease stage
- Have access to required equipment/technology for performing videoconsultation
Exclusion Criteria:
- Newly referred NET patients, who are visiting the department of Medical Oncology at the UMCG for the first time
- Recently diagnosed NET patients, who are in the diagnostic phase of the disease
- NET patients who frequently require blood tests, consultation or physical examination
- A hearing or visual impairment, which would make videoconsultation difficult
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Videoconsultation
Performing two videoconsulations with the treating medical oncologist
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Feasibility
Periodo de tiempo: 1 year
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Participation rates, reason for declining participation, number of completed videoconsultations, dropout rate and reason for dropout will be noted in study records to evaluate feasibility of videoconsultation
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Amount of time
Periodo de tiempo: 1 year
|
The amount of time NET patients are spending with videoconsultation in comparison with conventional outpatient clinic visits.
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1 year
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Acceptability and satisfaction of patients
Periodo de tiempo: 1 year
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The acceptability and satisfaction of patients with the use of videoconsultation will be assessed with a questionnaire and open-ended questions.
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1 year
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Acceptability and satisfaction of physicians
Periodo de tiempo: 1 year
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The acceptability and satisfaction of physicians with the use of videoconsultation will be assessed with a questionnaire and open-ended questions.
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: A.M.E. Walenkamp, MD PhD, University Medical Center Groningen
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
- VIDEO-NET-2014
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. .
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