Remote Monitoring in Cancer Care: A Platform Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1)
研究概览
简要总结
This study investigates a device that closely monitors vital signs, as well as a smartphone application (app) that allows patients to respond to different questions and tests that will monitor for new symptoms. This study may help researchers understand if wearing the device is a better tool than standard vital sign assessment tools done only while at the doctor's office or hospital, and if using the smartphone app is a better tool than standard assessment tools used while in the doctor's office or hospital.
详细描述
PRIMARY OBJECTIVES:
I. Develop patient-specific algorithms to predict the trajectory of cytokine release syndrome (CRS) and or neurotoxicity and time to escalation of medical intervention is needed. (Arm 1) II. Establish the validity for the use of mobile technology to assess neurologic symptoms remotely. (Arm 1) III. Compare the time to escalation of potential medical intervention between remote monitoring (RM) and standard care (SC) based on retrospective analysis of clinical trial data. (Arm 1) IV. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 1) V. Define the range of physiologic variables associated with receipt of radiation and chemotherapy. (Arm 2) VI. Correlate PROs and physician rated CTCAE to biologic parameters. (Arm 2) VII. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 2)
OUTLINE:
ARM 1: Patients undergoing CAR-T therapy use the Biofourmis wearable device(s) and smartphone app to answer a series of questions about health and neurologic symptoms a few times a day for 5 weeks.
ARM 2: Patients undergoing radiation therapy (RT) for head and neck, lung, or gastrointestinal cancers use the Biofourmis wearable device(s) for 60 to 90 days after completion of RT. Patients also use the smartphone app to answer a series of questions about health and neurologic symptoms before start of RT, after completion of RT, 3 months after completion of RT, and 1 year after completion of RT. In addition, patients complete weekly questionnaires regarding side effects and tolerance of the device.
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
- 否
入选标准
- •ARM 1: Age >= 18 years
- •ARM 1: Provide written informed consent
- •ARM 1: Patients undergoing commercial CAR-T cell therapy in an outpatient setting
- •ARM 2: Age >= 18 years
- •ARM 2: Provide written informed consent
- •ARM 2: Patients with a plan to undergo radiation therapy for lung, gastrointestinal, or head and neck cancer
排除标准
- •ARM 1: Non-English speaking
- •ARM 1: Planned initiation of lymphodepleting chemotherapy in the inpatient setting
- •ARM 2: Non-English speaking
结局指标
主要结局
Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1)
时间窗: Up to 5 weeks
Assessment of neurotoxicity via digital capture of neurological assessment (Arm 1)
时间窗: Up to 5 weeks
Will assess agreement and concordance between assessment of neurotoxicity via digital capture of neurological assessment (ICE) as compared to standard in-person assessment.
BF-Mayo Neuro test (Arm 1)
时间窗: Up to 5 weeks
Will assess agreement and concordance between BF-Mayo Neuro test and ICE-based assessment of neurotoxicity.
Sensitivity, specificity, positive predictive value and negative predictive value of novel digital neurotoxicity tests (BF-Neuro) (Arm 1)
时间窗: Up to 5 weeks
Will compare to standard in-person ICE based neurotoxicity assessment.
Range of physiologic variables associated with receipt of radiation and chemotherapy (Arm 2)
时间窗: Up to 1 year
Quantification of false alerts and downstream clinical actions (Arm 2)
时间窗: Up to 1 year
Will be used for the establishment of the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters.
次要结局
- Biovital index (Arm 1)(Up to 5 weeks)
- Point-in-time assessment of physiological signals from standard of care devices (Arm 1)(Up to 5 weeks)
- BF-Mayo Neuro Test (Arm 1)(Up to 5 weeks)
- Point-in-time assessment of physiological signals from wearable devices (Arm 1)(Up to 5 weeks)