Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT
ConditionCancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
All genders aged ≥ 18 years of age.
English-speakers
Able to understand and cooperate with study procedures.
Signed and dated informed consent.
Disqualifiers
None
Trial population
Adult subjects were diagnosed with cancer and prescribed concurrent systemic therapy and radiation therapy and their providers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
20 Participants
are grouped into 1 trial groupGroup A: Biometric Data Collection
Trial outcomes
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.
Time frame
Up to 12 weeksSecondary outcomes
1
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.
Time frame
Up to 12 weeks2
Subject perception of the utility
The subjects' responses to the utility of wearable health technology data will be quantified using surveys.
Time frame
Up to 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: