Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

UNC Lineberger Comprehensive Cancer Center

Status: Begins enrollment in 1 month

Conditions: Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05937659

LCCC2237

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

20 participants in 1 patient group

Biometric Data Collection

Description:

Adult subjects with cancer and prescribed concurrent systemic therapy and radiation therapy and enrolled in the study.