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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05937659
Other study ID # LCCC2237
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 15, 2024
Est. completion date March 15, 2025

Study information

Verified date October 2023
Source UNC Lineberger Comprehensive Cancer Center
Contact Victoria Xu
Phone +1 984-974-8744
Email victoria_xu@med.unc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date March 15, 2025
Est. primary completion date March 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Novant Health Cancer Institute Radiation Oncology Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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