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Tragbare Aktivitätsverfolgung zur Eindämmung von Krankenhausaufenthalten (WATCH)

21. September 2026 aktualisiert von: University of California, San Francisco

Tragbare Aktivitätsverfolgung zur Eindämmung von Krankenhausaufenthalten (ANSCHAUEN)

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

260

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult patients undergoing non-interventional, standard of care, radiotherapy (RT) at UCSF Department of Radiation Oncology

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Observational Group I: Fitbit only

Participants receive Fitbit device while undergoing non-interventional, standard of care, radiation therapy.

Participants will wear Fitbit device

Andere Namen:
  • Tragbarer Aktivitäts-Tracker
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

Andere Namen:
  • Tragbarer Aktivitäts-Tracker

Participants will wear personal device and share data with study team.

Andere Namen:
  • Apple-Uhr
  • iPhone

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Area under the receiver operating characteristic curve (AUC-ROC) of the step count model
Zeitfenster: 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
Calculation of a Brier Score
Zeitfenster: 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
Calculation of Log-Loss Score
Zeitfenster: 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
Area Under the Precision-Recall Curves (AUCPR)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
AUC-ROC for composite acute care
Zeitfenster: 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
Zeitfenster: 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
Mean squared error (MSE)
Zeitfenster: 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
Area under the receiver operating characteristic curve (AUC-ROC) for the composite acute care endpoint..
Zeitfenster: Up to 3 years

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Julian Hong, MD, MS, University of California, San Francisco

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

7. April 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

4. September 2024

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. September 2024

Zuerst gepostet (Tatsächlich)

19. September 2024

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 23722
  • NCI-2024-06762 (Registrierungskennung: NCI Clinical Trial Reporting Program (CTRP))
  • R01CA277782 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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