Seguimiento de actividad portátil para frenar las hospitalizaciones (WATCH)
Seguimiento de actividad portátil para frenar las hospitalizaciones (MIRAR)
This study is being done to collect patient generated health data to predict the risk of patients needing emergency department visits or hospitalization before, during. and after receiving radiation therapy.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVE:
I. Validate a previously developed step-count model for predicting all-cause acute care (pooled across all devices).
SECONDARY OBJECTIVES:
I. Validate a previously developed model for predicting each ED visits or hospitalizations during external beam RT using continuous step counts before, during, and after treatment.
II. Validate the previously developed step-count model for predicting all-cause acute care for each of the two different device platforms.
III. Validate concordance of step counts across each of the device's platforms in the Apple group.
IV. Validate the previously developed SHIELD-RT Electronic health record (EHR)-based model for predicting unplanned acute care (ED visit or hospitalization).
EXPLORATORY OBJECTIVES:
I. Refinement of the pre-existing models(step count and SHIELD-RT). II. Evaluate association between wearables collected parameters, EHR-based variables, and acute care events.
III. Develop and validate a multi-modal predictive model for predicting acute care.
OUTLINE: This is an observational study. Participants are assigned to 1 of 2 groups.
- GROUP I: Participants receive Fitbit device and undergo non-interventional, standard of care, radiation therapy.
- GROUP II: Participants receive Fitbit device and utilize their own personal Apple HealthKit-based device and undergo non-interventional, standard of care, radiation therapy.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Imani Dunn
- Número de teléfono: 877-827-3222
- Correo electrónico: Imani.Dunn@ucsf.edu
Ubicaciones de estudio
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California
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San Francisco, California, Estados Unidos, 94143
- Reclutamiento
- University of California, San Francisco
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Contacto:
- Correo electrónico: cancertrials@ucsf.edu
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Investigador principal:
- Julian Hong, MD, MS
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Contacto:
- Imani Dunn
- Número de teléfono: 877-827-3222
- Correo electrónico: Imani.Dunn@ucsf.edu
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult patients undergoing non-interventional, standard of care, radiotherapy (RT) at UCSF Department of Radiation Oncology
Descripción
Inclusion Criteria:
- Age >= 18.
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 or Karnofsky Performance Scale (KPS) >= 50%.
- Able to understand study procedures and to comply with them for the entire length of the study.
- Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.
- Diagnosis of invasive malignancy.
- Able to ambulate independently (without the assistance of a cane or walker).
- Planned treatment with fractionated external beam radiotherapy over at least 5 days (no fractional requirement).
- Not a previous participant on this protocol for subsequent courses.
Exclusion Criteria:
- Participants bound to a wheelchair.
- Participants unable to ambulate independently (needing assistance of cane or walker).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Observational Group I: Fitbit only
Participants receive Fitbit device while undergoing non-interventional, standard of care, radiation therapy. |
Participants will wear Fitbit device
Otros nombres:
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Observational Group II: Fitbit + Apple HealthKit
Participants receive Fitbit device and will utilize personal Apple HealthKit-based devices (iPhone, Apple Watch, etc.) to concurrently contribute Apple HealthKit-based data while undergoing non-interventional, standard of care, radiation therapy. |
Participants will wear Fitbit device
Otros nombres:
Participants will wear personal device and share data with study team.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Area under the receiver operating characteristic curve (AUC-ROC) of the step count model
Periodo de tiempo: Up to 3 years
|
The AUC-ROC of the step count model will measure the performance of a classification model by plotting the rate of true positives against false positives, and the score ranges from 0 - 1. The higher the AUC, the better the model's performance at distinguishing between the positive and negative classes. The AUC-ROC will be reported including both estimates and confidence intervals. All models will be reported per up-to-date guidelines, such as Minimum Information about Clinical Artificial Intelligence Modeling (MI-CLAIM) and Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD). The performance metrics will only be calculated with respect to first acute care event. |
Up to 3 years
|
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Calculation of a Brier Score
Periodo de tiempo: Up to 3 years
|
The Brier Score is a strictly proper score function or strictly proper scoring rule that measures the accuracy of probabilistic predictions. A Brier Score can take on any value between 0 and 1, with 0 being the best score achievable and 1 being the worst score achievable. The lower the Brier Score, the more accurate the prediction(s). The score will be reported including both estimates and confidence intervals. All models will be reported per up-to-date guidelines, such as MI-CLAIM and TRIPOD. The performance metrics will only be calculated with respect to first acute care event. |
Up to 3 years
|
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Calculation of Log-Loss Score
Periodo de tiempo: Up to 3 years
|
Logarithmic loss indicates how close a prediction probability comes to the actual/corresponding true value. The Log-Loss Score can take on any value between 0 and 1. The more the predicted probability diverges from the actual value, the higher is the log-loss value. The log-loss value will be reported including both estimates and confidence intervals. All models will be reported per up-to-date guidelines, such as MI-CLAIM and TRIPOD. The performance metrics will only be calculated with respect to first acute care event. |
Up to 3 years
|
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Area Under the Precision-Recall Curves (AUCPR)
Periodo de tiempo: Up to 3 years
|
The area under the precision-recall curve (AUCPR) is a single number summary of the information in the precision-recall (PR) curve. It represents the tradeoff between precision and recall for different thresholds, where high AUCPR indicates both high recall and high precision. The AUCPR will be reported including both estimates and confidence intervals. All models will be reported per up-to-date guidelines, such as MI-CLAIM and TRIPOD. The performance metrics will only be calculated with respect to first acute care event. |
Up to 3 years
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
AUC-ROC for composite acute care
Periodo de tiempo: Up to 3 years
|
The AUC-ROC will be used to validate a previously developed model in the primary endpoint for predicting each ED visits or hospitalizations during external beam RT using continuous step counts before, during, and after treatment. |
Up to 3 years
|
|
Area under the receiver operating characteristic curve (AUC-ROC) for all cause acute care by group
Periodo de tiempo: Up to 3 years
|
The AUC-ROC will be used to validate the previously developed step-count model in the primary endpoint for predicting all-cause acute care for each of the two different device platforms. |
Up to 3 years
|
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Mean squared error (MSE)
Periodo de tiempo: Up to 3 years
|
The MSE will be used to validate concordance of step counts across each of the device's platforms in the Apple group. Mean Squared Error (MSE) is a fundamental concept in statistics and machine learning in assessing the accuracy of the predictive models which measures the average squared difference between predicted values and the actual values in the dataset. |
Up to 3 years
|
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Area under the receiver operating characteristic curve (AUC-ROC) for the composite acute care endpoint..
Periodo de tiempo: Up to 3 years
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Validate the previously developed SHIELD-RT EHR-based model for predicting unplanned acute care (ED visit or hospitalization) to discover additional variables which may be predictors not previously included. |
Up to 3 years
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: Julian Hong, MD, MS, University of California, San Francisco
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- 23722
- NCI-2024-06762 (Identificador de registro: NCI Clinical Trial Reporting Program (CTRP))
- R01CA277782 (Subvención/contrato del NIH 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.
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