Wearable Activity Tracking to Curb Hospitalizations (WATCH)

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Lymphatic System Neoplasm; Hematopoietic Neoplasm; Malignant Solid Neoplasm

Treatments: Device: Apple HealthKit-based devices; Device: Fitbit

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06587100

23722

R01CA277782 (U.S. NIH Grant/Contract)

NCI-2024-06762 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

260 participants in 2 patient groups

Observational Group I: Fitbit only

Description:

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

Treatment:

Device: Fitbit

Observational Group II: Fitbit + Apple HealthKit

Description:

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.

Treatment:

Device: Fitbit

Device: Apple HealthKit-based devices