Wearable Activity Tracking to Curb Hospitalizations (WATCH)

Wearable Activity Tracking to Curb Hospitalizations (WATCH)

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic Neoplasm; Lymphatic System Neoplasm
• Intervention / Treatment: Device: Fitbit; Device: Apple HealthKit-based devices

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 260

Contacts and Locations

• Study Contact: Name: Imani Dunn; Phone Number: 877-827-3222; Email: imani.dunn@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Email: cancertrials@ucsf.edu
      • Principal Investigator: Julian Hong, MD, MS
      • Contact: Imani Dunn; Phone Number: 877-827-3222; Email: imani.dunn@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational Group I: Fitbit only; Participants receive Fitbit device while undergoing non-interventional, standard of care, radiation therapy.	Device: Fitbit; Participants will wear Fitbit device; Other Names: Wearable Activity 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.	Device: Fitbit; Participants will wear Fitbit device; Other Names: Wearable Activity Tracker; Device: Apple HealthKit-based devices; Participants will wear personal device and share data with study team.; Other Names: Apple watch; iPhone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the receiver operating characteristic curve (AUC-ROC) of the step count model	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	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	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)	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC-ROC for composite acute care	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	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)	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..	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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Julian Hong, MD, MS, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 4, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Activity tracking; Hospitalization prevention; Artificial Intelligence (AI) modelling
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: 23722; NCI-2024-06762 (Registry Identifier: NCI Clinical Trial Reporting Program (CTRP)); R01CA277782 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No