Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

Incorporating Biometric Data Evaluation for Patients Receiving Concurrent Chemotherapy and Radiation Therapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cancer

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Victoria Xu; Phone Number: +1 984-974-8744; Email: victoria_xu@med.unc.edu
• Study Contact Backup: Name: Crystal Walker; Email: Crystal.Walker@unchealth.unc.edu

Study Locations

• United States
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Novant Health Cancer Institute Radiation Oncology
      • Contact: Bridgette Cline; Phone Number: 910-667-7259; Email: Bridgette.Cline@novanthealth.org
      • Principal Investigator: Alison Amos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult subjects were diagnosed with cancer and prescribed concurrent systemic therapy and radiation therapy and their providers.

Description

Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Subjects

1. All genders aged ≥ 18 years of age.
2. English-speakers
3. Able to understand and cooperate with study procedures.
4. Signed and dated informed consent.
5. Subjects being seen at Novant-New Hanover Regional Medical Center for diagnosis and management of cancer.
6. Subjects prescribed to receive concurrent radiation therapy and systemic therapy either definitively or postoperatively.
7. Signed and dated HIPAA authorization for the release of personal health information.

Providers

1. All genders aged ≥ 18 years of age.
2. English speakers.
3. Able to understand and cooperate with study procedures.
4. Signed and dated informed consent.

Exclusion Criteria Both Subjects and care providers

1. Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Biometric Data Collection; Adult subjects with cancer and prescribed concurrent systemic therapy and radiation therapy and enrolled in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of technology adoption	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.	Up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider perception of the utility	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.	Up to 12 weeks
Subject perception of the utility	The subjects' responses to the utility of wearable health technology data will be quantified using surveys.	Up to 12 weeks

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Alison Amos, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 10, 2023

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: chemotherapy; radiation therapy; biometric data; wearable health technology
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LCCC2237

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No