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Идёт набор NCT06587100

Wearable Activity Tracking to Curb Hospitalizations

— Наблюдательное Hematopoietic Neoplasm Malignant Solid Neoplasm Lymphatic System Neoplasm

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Fitbit, Apple HealthKit-based devices.
Кому может быть актуально
Состояния в реестре: Hematopoietic Neoplasm, Malignant Solid Neoplasm, Lymphatic System Neoplasm. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Wearable Activity Tracking to Curb Hospitalizations (WATCH)

Обзор

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.

Подробное описание

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.

Вмешательства

  • Устройство Fitbit
    Participants will wear Fitbit device
  • Устройство Apple HealthKit-based devices
    Participants will wear personal device and share data with study team.

Первичные конечные точки

  • Area under the receiver operating characteristic curve (AUC-ROC) of the step count model [Срок оценки: Up to 3 years]
  • Calculation of a Brier Score [Срок оценки: Up to 3 years]
  • Calculation of Log-Loss Score [Срок оценки: Up to 3 years]
  • Area Under the Precision-Recall Curves (AUCPR) [Срок оценки: Up to 3 years]
Вторичные конечные точки (4)
  • AUC-ROC for composite acute care [Срок оценки: Up to 3 years]
  • Area under the receiver operating characteristic curve (AUC-ROC) for all cause acute care by group [Срок оценки: Up to 3 years]
  • Mean squared error (MSE) [Срок оценки: Up to 3 years]
  • Area under the receiver operating characteristic curve (AUC-ROC) for the composite acute care endpoint.. [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

  • Age >= 18.
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 2.
  • 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.

Критерии исключения

  • Participants bound to a wheelchair.
  • Participants unable to ambulate independently (needing assistance of cane or walker).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 1 центр
  • University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT06587100 · 23722 · NCI-2024-06762 · R01CA277782

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗