Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer

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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Biometric Data Collection<br>Adult subjects with cancer and prescribed concurrent systemic therapy and radiation therapy and enrolled in the study. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation therapy, chemotherapy, biometric data, wearable health technology