Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

Not yet recruiting

• Conditions: Cancer

• Registration Number: NCT05937659
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

This study will assess the feasibility of incorporating biometric data via wearable health technology (WHT) into the radiation oncology (RO) clinic workflow for patients receiving concurrent radiation therapy and systemic therapy (CRT) for cancer. The investigators hypothesize that a practical workflow could be created within a busy community RO practice that will allow providers and patients to readily appreciate physiologic declines during concurrent CRT.

Subjects will be asked to wear a device as part of this study that will collect their biometric data (heart rate, number of steps taken per day, etc) called a WHT device throughout their treatment and for 4 weeks afterward. Subjects will be asked to upload the data from their devices onto the computers in the clinic for the assessment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Study Start: 2025-05-15
• Primary Completion: 2027-03-15
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of technology adoption	Up to 12 weeks	The rate of technology adoption will be quantified as the fraction of subjects who successfully download their WHT data into the research databases in the radiation oncology clinic. Success, on a subject-specific basis, will be defined as their reporting any of their WHT biometric data on \>40% of eligible days.

Secondary Outcome Measures

Name	Time	Method
Provider perception of the utility	Up to 12 weeks	The physician's and nurse's subjective assessment of the utility of having the subject's wearable health technology data such as enhanced dietary or hydration counseling, supportive medication alteration, and/or intravenous fluid hydration will be quantified, using a survey.
Subject perception of the utility	Up to 12 weeks	The subjects' responses to the utility of wearable health technology data will be quantified using surveys.

Trial Locations

Locations (1)

Novant Health Cancer Institute Radiation Oncology; 🇺🇸 Wilmington, North Carolina, United States