Incorporating Biometric Data Evaluation for Patients Receiving Concurrent Chemotherapy and Radiation Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The rate of technology adoption
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- •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.
- •All genders aged ≥ 18 years of age.
- •English speakers.
- •Able to understand and cooperate with study procedures.
- •Signed and dated informed consent.
排除标准
- •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
研究组 & 干预措施
Biometric Data Collection
Adult subjects with cancer and prescribed concurrent systemic therapy and radiation therapy and enrolled in the study.
结局指标
主要结局
The rate of technology adoption
时间窗: Up to 12 weeks
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.
次要结局
- Provider perception of the utility(Up to 12 weeks)
- Subject perception of the utility(Up to 12 weeks)