A Pilot Prospective Clinical Trial Using Remote Patient Monitoring for Cancer Patients Undergoing Outpatient Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- The Use of Locus Heath iPhone App and the Apple Watch by Participants Undergoing Outpatient Chemotherapy.
研究概览
简要总结
A pilot study using remote monitoring technology developed by Locus Health in cancer patients undergoing chemotherapy treatment.
详细描述
Modern-day wearable devices, such as Apple Watches or Fitbits, are widely available, non-invasive, and can provide continuous vital sign monitoring for the early detection of potential health complications. Early detection of things such as fever or increased heart rate can alert patients to seek medical attention sooner and therefore have the potential to improve patient outcomes and decrease healthcare costs.
To further investigate the feasibility of using remote patient monitoring ( RPM)to prospectively monitor patients undergoing outpatient chemotherapy for chemotherapy related toxicities, defined as follows: (1) patients answer queries through the Locus Health iPhone app at least 70% of the time; (2) patients report that the Locus Health iPhone app and the Apple Watch were 'easy to use,' defined as an average score of 7 or higher on the first two questions of the post-intervention questionnaire, and (3) fewer than 10% of patients withdraw from the study.
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
- •Planned to be treated with a new cytotoxic chemotherapy or chemoimmunotherapy regimen for a solid tumor or malignant hematology condition for at least 4 months
- •ECOG performance status of 0-2
- •Age of 18 or older patient with any solid tumor or hematologic malignancy
- •English or Spanish speaker
- •Own an Apple iPhone
- •Capacity and willingness to provide informed consent
排除标准
- •Patients undergoing concurrent radiation since they will be seen on a daily basis by clinic care teams and are not likely to benefit from active remote patient monitoring
- •Patients unwilling or unable to comply with the protocol, including wearing the Apple Watch (including recharging daily) and answering queries on the Locus Health iPhone application per the protocol and study group cadence
- •Any condition for which in the Investigator's opinion would limit compliance with study requirements
研究组 & 干预措施
3 Cohorts
Cohort 1: Daily from day 2 through the end of treatment cycle (n=34) Cohort 2: Daily days 2-9 then every third day through end of cycle (n=33) Cohort 3: Daily days 2-9 for all symptoms, every third day thereafter regarding 'pain' only through end of cycle (n=33)
干预措施: Locus Health iPhone App (Device)
结局指标
主要结局
The Use of Locus Heath iPhone App and the Apple Watch by Participants Undergoing Outpatient Chemotherapy.
时间窗: 120 days or until the chemotherapy regimen has stopped, whichever is sooner
The feasibility is determined when 80% of the patients wear the watch at least 70% of the time during waking hours.
次要结局
未报告次要终点