Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

NCT05937659 | Not Yet Recruiting DMC

• 1 other identifier: LCCC2237
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

radiation therapy; chemotherapy; biometric data; wearable health technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Provider perception of the utility

  Up to 12 weeks

• Subject perception of the utility

  Up to 12 weeks

Study Arms (1)

Biometric Data Collection

Adult subjects with cancer and prescribed concurrent systemic therapy and radiation therapy and enrolled in the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Novant Health Cancer Institute Radiation Oncology

Wilmington, North Carolina, 28401, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Lukasz Mazur, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Xu

CONTACT

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

Crystal Walker

CONTACT

Crystal.Walker@unchealth.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)