Clinical trial NCT05937659: Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT
Official title: Incorporating Biometric Data Evaluation for Patients Receiving Concurrent Chemotherapy and Radiation Therapy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Keywords: radiation therapy
chemotherapy
biometric data
wearable health technology
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-07-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult subjects were diagnosed with cancer and prescribed concurrent systemic therapy and radiation therapy and their providers.

Brief 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.


Eligibility 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

Primary outcomes:
measure: The rate of technology adoption
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Provider perception of the utility
timeFrame: Up to 12 weeks
measure: Subject perception of the utility
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Novant Health Cancer Institute Radiation Oncology
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Lukasz Mazur, MD
role: PRINCIPAL_INVESTIGATOR
References: