Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05937659

Enrollment

Registered

2023-07-10

Start date

2026-09-15

Completion date

2027-10-30

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

radiation therapy, chemotherapy, biometric data, wearable health technology

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTVictoria Xu

victoria_xu@med.unc.edu+1 984-974-8744

CONTACTCrystal Walker

Crystal.Walker@unchealth.unc.edu

PRINCIPAL_INVESTIGATORAlison Amos, MD

UNC Lineberger Comprehensive Cancer Center

Outcome results