Una Plataforma de Autocontrol para el Seguimiento de la Seguridad de la Medicación y las Preocupaciones en Pacientes con Cáncer
Participación del Paciente en el Uso de la Tecnología para el Autoseguimiento de Eventos de Seguridad de la Medicación
This clinical trial evaluates the usefulness of a self-monitoring platform for tracking medication safety events and concerns in patients with lung, colorectal, breast, and prostate cancer. Patients receiving oral anticancer agents often encounter challenges in managing complex treatment regimens, potentially life-threatening toxicities, and drug-drug and drug-food interactions at home. To achieve the goal of medication safety, they need to become "vigilant partners" in medication and toxicity self-monitoring, including timely reporting of medication events to clinicians when their care transitions back home. In this study, patients use an online self-monitoring platform to track their experiences or concerns about taking their medications, including their experiences with symptoms. This platform may be a useful way for patients to track problems they have when taking their medications at home and may help them take better care of their health.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Comprehensive Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participants are adult patients (aged 18 years or older)
- Diagnosed with lung, colorectal, breast, or prostate cancer
- Are currently receiving active cancer treatments
- Are self-managing one or more prescribed cancer medications
- Participants must have access to technology devices (smartphone, tablet, computer) to track their experiences or concerns about medication safety events, or their family members can help them access technology devices to track the events or concerns
- Speaks and reads English or has a support person (family member or friend) who can assist
Exclusion Criteria:
- Can't access technology or do not use technology
- Do not have access to the internet
- Do not speak or read English
- Not permitted to participate by their health care providers
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Health services research (self-monitoring platform)
Patients use the self-monitoring platform to track medication-related safety events and issues at home for 6 months. Patients may receive relevant educational materials and resources via the platform or by email and/or receive follow-up contact from a nurse practitioner as needed over the 6 months. Patients are encouraged to continue using the platform for an additional 6 months after the study period, as desired. |
Ancillary studies Ancillary studies Ancillary studies Receive educational materials and resources
Otros nombres:
Receive follow-up contact
Otros nombres:
Use self-monitoring platform |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-reported system usability
Periodo de tiempo: Up to 6 months
|
Self-reported system usability will be assessed using the 10-item System Usability Scale. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Perceived usefulness
Periodo de tiempo: Up to 6 months
|
Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 6 months
|
|
Ease of use
Periodo de tiempo: Up to 6 months
|
Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 6 months
|
|
Attitudes toward use
Periodo de tiempo: Up to 6 months
|
Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 6 months
|
|
Intention to use and continuous use of the system over time
Periodo de tiempo: Up to 12 months
|
Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 12 months
|
|
Self-reported patient engagement
Periodo de tiempo: Up to 6 months
|
Self-reported patient engagement will be measured by the 9-item Twente Engagement with Ehealth Technologies Scale (TWEETS), including three dimensions, behavioral engagement, cognitive engagement, and affective engagement. Will use the overall TWEETS score to evaluate patient engagement in this study, rather than analyzing each dimension separately. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. Will use repeated measures analysis of variance to assess the changes in mean scores of patient engagement. Univariate associations between baseline personal and clinical factors and patient engagement at each time point will be assessed using correlation analyses (Pearson or Spearman), Chi-square tests, or non-parametric Mann-Whitney U tests, depending on the variable types. Multiple linear regressions will be conducted to assess associations between patient engagement and outcomes. |
Up to 6 months
|
|
System usage over time
Periodo de tiempo: Up to 12 months
|
Will be objectively recorded by the system logs and analyzed using Google Analytics (dashboard only), including parameters like the number of logins, number of tab pages clicked, number of events or concerns self-tracked, and more. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 12 months
|
|
Patient activation levels
Periodo de tiempo: Up to 6 months
|
Patient activation levels will be measured by the Short Form of Patient Activation Measure. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Medication self-management ability
Periodo de tiempo: Up to 6 months
|
Medication self-management ability will be measured by the Measure of Medication Self-Management. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Symptom distress
Periodo de tiempo: Up to 6 months
|
Symptom distress will be measured by the 19-item MD Anderson Symptom Inventory. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Health related quality of life
Periodo de tiempo: Up to 6 months
|
Health-related quality of life will be measured by the 27-item Functional Assessment of Cancer Therapy - General. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 6 months
|
|
Number of emergency room visits
Periodo de tiempo: Up to 12 months
|
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 12 months
|
|
Number of hospitalizations
Periodo de tiempo: Up to 12 months
|
Will be measured by both self-report and chart review. Will use descriptive statistics, such as mean and standard deviation for continuous variables, and frequency and percentage for categorical variables. |
Up to 12 months
|
|
User experiences with the system
Periodo de tiempo: Up to 6 months
|
Participants' user experiences with the system, such as perceived facilitators or barrios to system use, along with their suggestions for system improvement, will be collected through a brief individual interview. Qualitative data, including brief interview data will be analyzed and summarized through content analysis. |
Up to 6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-tracked, structured medication safety events or concerns
Periodo de tiempo: Up to 12 months
|
To understand the nature and causes of events and concerns, self-tracked, structured medication safety events or concerns tracking data from the system, such as the number and types of events or concerns self-tracked, will be summarized using descriptive statistics. The free-text tracking data from the system will be analyzed and summarized through content analysis or natural language processing techniques, depending on data volume. |
Up to 12 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Yun Jiang, University of Michigan Rogel Cancer Center
- Investigador principal: Yang Gong, UTHealth Houston McWilliam School of Biomedical Informatics
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Enfermedades intestinales
- Enfermedades de las vías respiratorias
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades pulmonares
- Neoplasias de las vías respiratorias
- Neoplasias torácicas
- Enfermedades del Colon
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias prostáticas
- Neoplasias Pulmonares
- Neoplasias colorrectales
- Neoplasias de mama
- Calidad, acceso y evaluación de la atención médica
- Técnicas de investigación
- Métodos epidemiológicos
- Recopilación de datos
- Mecanismos de evaluación de atención médica
- Calidad de la atención médica
- Salud pública
- Medio ambiente y salud pública
- Servicios de salud
- Instalaciones de atención médica Fuerza laboral y servicios
- Servicios de salud infantil
- Servicios de salud comunitarios
- Servicios de salud preventivos
- Factores socioeconómicos
- Características de la población
- Técnicas inmunológicas
- Técnicas genéticas
- Estudios epidemiológicos
- Características del estudio epidemiológico
- Inmunoprecipitación de cromatina
- Secuenciación de nucleótidos de alto rendimiento
- Análisis de secuencia
- Análisis de secuencia, ADN
- Inmunoprecipitación
- Estudios de cohorte
- Métodos
- Entrevistas como tema
- Intervención temprana, educativa
- Estado educativo
- Secuenciación de inmunoprecipitación de cromatina
- Estudios de seguimiento
Otros números de identificación del estudio
- UMCC 2025.050
- NCI-2025-08754 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- HUM00272763 (Otro identificador: University of Michigan)
- R01HS027846 (Subvención/Contrato de la AHRQ de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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