Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Incorporating Biometric Data Evaluation for Patients Receiving Concurrent Chemotherapy and Radiation Therapy
Overview
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.
Primary outcome measures
- The rate of technology adoption [Time frame: Up to 12 weeks]
Secondary outcome measures (2)
- Provider perception of the utility [Time frame: Up to 12 weeks]
- Subject perception of the utility [Time frame: Up to 12 weeks]
Eligibility criteria
Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
Subjects
- All genders aged ≥ 18 years of age.
- English-speakers
- Able to understand and cooperate with study procedures.
- Signed and dated informed consent.
- Subjects being seen at Novant-New Hanover Regional Medical Center for diagnosis and management of cancer.
- Subjects prescribed to receive concurrent radiation therapy and systemic therapy either definitively or postoperatively.
- Signed and dated HIPAA authorization for the release of personal health information.
Providers
- All genders aged ≥ 18 years of age.
- English speakers.
- Able to understand and cooperate with study procedures.
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Novant Health Cancer Institute Radiation Oncology — Wilmington
Identifiers
NCT: NCT05937659 · LCCC2237