Wearable Integration in Symptom Evaluation for Cancer Survivors (WISE)

April 20, 2026 updated by: Gabrielle Rocque, University of Alabama at Birmingham

Evaluating the Implementation and Impact of Navigator-Delivered ePRO Home Symptom Monitoring and Management - Wearable Integration in Symptom Evaluation for Cancer Survivors

The objective of this work is the production of actionable insights that can be leveraged to improve remote symptom monitoring (RSM) in varied practice settings, which in turn, is expected to improve timely, efficient, and high-quality comprehensive care in oncology. Aim 1: To assess the feasibility of incorporating a wearable into an RSM program for patients receiving cancer treatment. Aim 2: To assess the relationship between the wearable and ePRO-reported physical symptoms and functional status. Aim 3: To characterize barriers and facilitators of using the wearable in the RSM program and suggest approaches to incorporating relevant evidence-based interventions.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Remote symptom monitoring (RSM) using electronic patient-reported outcomes (ePROs) benefits patients with cancer on active treatment (i.e., improved symptom assessment efficiency, patient-clinician communication and satisfaction, symptom control and well-being, overall survival). Despite promising RSM results, low sustained adherence and the limited amount of symptom information that can be feasibly captured through surveys limit RSM benefits. Passive data collection through wearable technology may strengthen RSM benefits by providing a more complete and continuous picture of patient health, without substantial patient and system burden. For this investigation, we leverage our existing RSM infrastructure to test the integration of a wearable for enhanced monitoring.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria: (1) ≥18 years of age; (2) diagnosed with cancer; (3) enrolled in the ePRO RSM program at O'Neal CCC; (4) uses a smart phone compatible with the wearable.

Exclusion criteria: (1) Lack of English fluency and literacy; (2) Medical condition that makes the person unable to participate, at PI discretion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Group - Wearable
Patients are given a wearable to use which tracks physiological health metrics (e.g., sleep, activity, heart rate variability)
Other: Wearable
Patient participants are provided with an industry-leading wearable with multiple research-grade sensors that measure physiological indicators such as temperature, HRV, sleep, and physical activity, with high accuracy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility thresholds for uptake and compliance
Time Frame: 6 months
% of eligible patients agree to wearable use and % adherence
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

Breast Cancer Research Foundation of Alabama

Investigators

  • Principal Investigator: Gabrielle Rocque, MD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300007406-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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