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Recruiting NCT06587100

Wearable Activity Tracking to Curb Hospitalizations

— Observational Hematopoietic Neoplasm Malignant Solid Neoplasm Lymphatic System Neoplasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fitbit, Apple HealthKit-based devices.
Who it may be relevant to
Registry conditions: Hematopoietic Neoplasm, Malignant Solid Neoplasm, Lymphatic System Neoplasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Wearable Activity Tracking to Curb Hospitalizations (WATCH)

Overview

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.

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗