Monitoreo de software de las toxicidades relacionadas con el tratamiento en el carcinoma de células renales avanzado
15 de abril de 2026 actualizado por: Chunkit Fung, University of Rochester
Monitoreo de las toxicidades relacionadas con el tratamiento con agentes orales dirigidos e inmunoterapia en pacientes con carcinoma de células renales (CCR) avanzado utilizando el software Carevive, un estudio de viabilidad de fase II de un solo brazo
Determinar si el software Carevive, que monitorea las toxicidades relacionadas con el tratamiento y luego genera planes de manejo de autocuidado para estos síntomas, será factible de implementar entre pacientes con carcinoma de células renales (CCR) metastásico.
Además, para la recopilación de datos preliminares sobre toxicidades relacionadas con el tratamiento, calidad de vida, nivel de angustia y adherencia a los medicamentos.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
21
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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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester - Wilmot Cancer Institute
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Descripción
Criterios de inclusión:
- Diagnóstico de carcinoma de células renales de cualquier subtipo confirmado histológicamente con evidencia patológica o radiográfica de enfermedad metastásica.
- Mayor de 18 años
- Un oncólogo participante del Wilmot Cancer Center ha determinado que el candidato debe comenzar con terapia oral dirigida o inmunoterapia para el tratamiento de su CCR avanzado; Esto puede ser para terapia de primera línea o cualquier terapia de línea posterior.
- Capaz de proporcionar consentimiento informado por escrito.
- Competente en el idioma inglés y se autoinforma como alfabetizado.
- Debe tener una dirección de correo electrónico activa o acceso a un dispositivo inteligente en el que se puedan recibir mensajes de texto.
Criterio de exclusión:
- Las mujeres no pueden estar amamantando
- No tiene acceso regular a Internet.
- No poder acudir al Wilmot Cancer Center para citas cada 3 o 4 meses para visitas de rutina con su oncólogo principal
- Los sujetos que participaron anteriormente en el estudio no podrán volver a inscribirse en caso de un cambio de tratamiento.
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: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Uso del software Carevive
Informe y gestión de los efectos secundarios de la terapia oral dirigida o la inmunoterapia, a través del software Carevive, en pacientes con carcinoma de células renales (CCR) avanzado.
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En este estudio, Carevive entregará un enlace a los sujetos para que se pueda completar una encuesta en línea.
La encuesta se realizará semanalmente durante las primeras 12 semanas del estudio y, a partir de entonces, se espaciará cada dos semanas.
Las preguntas se centrarán principalmente en los efectos secundarios de su terapia contra el cáncer, así como algunas preguntas sobre el cumplimiento de los medicamentos y la utilización de la atención médica.
Después de completar la encuesta, al sujeto se le brindará un plan de atención con opciones de autocontrol en el hogar para las toxicidades relacionadas con los medicamentos.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants Who Submitted at Least One Carevive Survey
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who completed at least one Carevive survey at any time during the 48 week study period.
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From enrollment through 48 weeks
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Percentage of Carevive Surveys Completed Per Participant
Periodo de tiempo: From enrollment through 48 weeks
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Percentage of Carevive surveys completed by each participant, calculated as the number of completed surveys divided by the number of surveys prompted by the Carevive software during the 48 week study period.
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From enrollment through 48 weeks
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Number of Participants Who Utilized at Least One Auto-Generated Carevive Care Plan
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who accessed at least one auto-generated Carevive care plan at any time during the 48 week study period.
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From enrollment through 48 weeks
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Percentage of Auto Generated Carevive Care Plans Utilized Per Participant
Periodo de tiempo: From enrollment through 48 weeks
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Percentage of auto generated Carevive care plans utilized by each participant, calculated as the number of care plans accessed divided by the total number of care plans generated for that participant during the 48 week study period.
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From enrollment through 48 weeks
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System Usability Scale (SUS) Score for Carevive Software
Periodo de tiempo: From enrollment through 48 weeks
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Participants completed the System Usability Scale (SUS), which is a validated 10-item questionnaire that produces a total usability score ranging from 0 to 100.
Scores are categorized into three main categories: excellent (>80.3 points); good (68.0 to 80.3 points) and below average (<68 points).
We calculated the SUS point for each participant who completed the survey.
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From enrollment through 48 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional Assessment of Cancer Therapy-Kidney Symptom Index (FKSI-DRS) Total Score
Periodo de tiempo: From enrollment through 48 weeks
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The FKSI-DRS is a validated patient-reported outcome measure assessing kidney cancer-related symptoms, with total scores ranging from 0 to 36, where higher scores indicate better quality of life.
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From enrollment through 48 weeks
|
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Distress Level Assessed by NCCN Distress Thermometer
Periodo de tiempo: From enrollment through 48 weeks
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The NCCN Distress Thermometer is a validated patient reported outcome measure assessing psychological distress on a scale from 0 to 10, with higher scores indicating greater distress.
Scores were categorized to reflect low distress (0-3) and moderate to severe distress (4-10).
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From enrollment through 48 weeks
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Health Care Utilization Assessment
Periodo de tiempo: From enrollment through 48 weeks
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Health care utilization was assessed based on participant self-report and defined as having at least one hospital visit, emergency room visit, or unplanned clinic visit during the 48-week study period.
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From enrollment through 48 weeks
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Participants Reporting Diarrhea
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported Diarrhea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Nausea
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported nausea (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Vomiting
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported vomiting (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Fatigue
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported fatigue (Yes or No) in response to PRO CTCAE survey questions assessing treatment related toxicities from oral targeted agents and immunotherapy.
Responses were collected using Carevive surveys administered weekly for the first 12 weeks and then every other week for an additional 36 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Rash
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported rash (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Abdominal Pain
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported abdominal pain (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Mouth Sores
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported mouth sores (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Cough
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported cough (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Shortness of Breath
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported Shortness of Breath (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting the symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Participants Reporting Anorexia
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants who self reported Anorexia (Yes or No) in response to PRO CTCAE survey questions assessing treatment related symptoms from oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Responses were collected using Carevive software surveys administered weekly for the first 12 weeks of the study and then every other week thereafter through 48 weeks.
Participants were counted as reporting this symptom if they answered "Yes" to the corresponding survey question during the specified time period.
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From enrollment through 48 weeks
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Clinician Reported Diarrhea
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants with clinician reported diarrhea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
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Clinician Reported Nausea
Periodo de tiempo: From enrollment through 48 weeks
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Number of participants with clinician reported nausea assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
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Clinician Reported Vomiting
Periodo de tiempo: From enrollment through 48 weeks
|
Number of participants with clinician reported vomiting assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
|
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Clinician Reported Fatigue
Periodo de tiempo: From enrollment through 48 weeks
|
Number of participants with clinician reported fatigue assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
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From enrollment through 48 weeks
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Clinician Reported Rash
Periodo de tiempo: From enrollment through 48 weeks
|
Number of participants with clinician reported Rash assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
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Clinician Reported Abdominal Pain
Periodo de tiempo: From enrollment through 48 weeks
|
Number of participants with clinician reported Abdominal Pain assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Mouth Sores
Periodo de tiempo: From enrollment through 48 weeks
|
Number of participants with clinician reported Mouth Sores assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Cough
Periodo de tiempo: From enrollment through 48 weeks
|
Number of participants with clinician reported Cough assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
|
Clinician Reported Shortness of Breath
Periodo de tiempo: From enrollment through 48 weeks
|
Number of participants with clinician reported Shortness of Breath assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
|
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Clinician Reported Anorexia
Periodo de tiempo: From enrollment through 48 weeks
|
Number of participants with clinician reported Anorexia assessed during in office clinic visits while receiving oral targeted therapy or immunotherapy for advanced renal cell carcinoma.
Clinicians recorded the presence or absence of this symptom at baseline and during follow up assessments conducted from enrollment through 48 weeks.
Responses were categorized as Yes, No, or Unknown based on clinician assessment.
These data are presented as longitudinal assessments of symptom occurrence over time.
Summary reporting of these events as adverse events is provided separately in the Adverse Events section.
|
From enrollment through 48 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
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 (Actual)
24 de julio de 2019
Finalización primaria (Actual)
14 de febrero de 2025
Finalización del estudio (Actual)
14 de febrero de 2025
Fechas de registro del estudio
Enviado por primera vez
18 de julio de 2017
Primero enviado que cumplió con los criterios de control de calidad
24 de julio de 2017
Publicado por primera vez (Actual)
25 de julio de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
7 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
15 de abril de 2026
Última verificación
1 de febrero de 2025
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Neoplasias Glandulares y Epiteliales
- Adenocarcinoma
- Neoplasias Urológicas
- Neoplasias Renales
- Carcinoma
- Carcinoma De Célula Renal
Otros números de identificación del estudio
- UGUK 17036
- UG1CA189961 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
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. .