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Trial Title:
Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT
NCT ID:
NCT05937659
Condition:
Cancer
Conditions: Keywords:
radiation therapy
chemotherapy
biometric data
wearable health technology
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Adult subjects were diagnosed with cancer and prescribed concurrent systemic therapy and
radiation therapy and their providers.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Novant Health Cancer Institute Radiation Oncology
Address:
City:
Wilmington
Zip:
28401
Country:
United States
Contact:
Last name:
Bridgette Cline
Phone:
910-667-7259
Email:
Bridgette.Cline@novanthealth.org
Investigator:
Last name:
Lukasz Mazur
Email:
Principal Investigator
Start date:
November 15, 2024
Completion date:
March 15, 2025
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05937659
