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Clinical Trials/NCT07463547
NCT07463547Enrolling By InvitationNot Applicable

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

University of Alabama at Birmingham1 site in 1 country20 target enrollmentStarted: April 17, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
20
Locations
1
Primary Endpoint
Feasibility thresholds for uptake and compliance

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Patient Group - Wearable

Experimental

Patients are given a wearable to use which tracks physiological health metrics (e.g., sleep, activity, heart rate variability)

Intervention: Wearable (Other)

Outcomes

Primary Outcomes

Feasibility thresholds for uptake and compliance

Time Frame: 6 months

% of eligible patients agree to wearable use and % adherence

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gabrielle Rocque

Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care

University of Alabama at Birmingham

Study Sites (1)

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