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NCT Number: NCT05937659

Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novant Health Cancer Institute Radiation Oncology

Wilmington, North Carolina, 28401, United States

Location contact

Bridgette Cline

CONTACT

[email protected]

910-667-7259

Lukasz Mazur

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Exclusion criteria

Both Subjects and care providers

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

Treatment and study plan

Primary outcomes

  1. The rate of technology adoption

    Time frame: 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 outcomes

  1. Provider perception of the utility

    Time frame: 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.

  2. Subject perception of the utility

    Time frame: Up to 12 weeks

    The subjects' responses to the utility of wearable health technology data will be quantified using surveys.

Study contacts

Contact information is provided by the study sponsor or research team.

Crystal Walker

CONTACT

[email protected]

Victoria Xu

CONTACT

[email protected]

+1 984-974-8744

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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