In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of Hospitalizations (Arm A only)
研究概览
简要总结
The investigators propose a pilot study of monitoring a sample of 6 older patients receiving active cancer treatment over a period of 6 months with in-home sensor monitors installed and maintained by Foresite Healthcare. The investigators also propose exploring the beliefs and attitudes of those who are not willing to allow in-home sensor monitoring by asking them to complete a brief survey related to in-home sensor monitoring. The investigators hypothesize that patients will find the equipment acceptable and unintrusive, that changes in home-monitored patient parameters will precede clinical events and that patient trajectories will be more fully characterized with the in home sensors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents OR will begin systemic therapy within the next 4 weeks.
- •Estimated life expectancy >1 year
- •Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- •Willing to have sensors installed in 1-2 primary living areas (e.g. living room and bedroom)
- •Continuous home internet connection
- •Able to understand and willing to sign an IRB-approved written informed consent document
- •Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents OR will begin systemic therapy within the next 4 weeks.
- •Estimated life expectancy >1 year
- •Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- •Able to understand and willing to sign an IRB-approved written informed consent document
排除标准
- •Inability to read and understand English
- •Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
- •Lives in institutional setting where instrumental activities of daily living are completed for patient by paid staff
- •Inability to read and understand English
- •Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
- •Lives in institutional setting where instrumental activities of daily living are completed for patient by paid staff
结局指标
主要结局
Number of Hospitalizations (Arm A only)
时间窗: 6 months
Number of Emergency room visits (Arm A only)
时间窗: 6 months
Number of Falls (Arm A only)
时间窗: 6 months
Heart rate (Arm A only)
时间窗: 6 months
-A meaningful change is heart rate outside the normal range of 60-100
Number of Infections requiring medical intervention (e.g. oral antibiotics) (Arm A only)
时间窗: 6 months
Acceptability of in-home sensor monitoring as measured by a modified version of the Intelligent Systems for Assessment of Aging Technology Survey (Arm A only)
时间窗: 6 months
* 11 questions about how the participant would feel about in-home sensor monitoring, the participant can choose from 1 = strongly agree to 5 = strongly disagree. A higher score means the participant that does not feel comfortable with in-home sensor monitoring * 2 questions about concerns about information gathered by the in-home sensor monitoring might be shared, answers range from 1 = very concerned to 4 = not concerned at all. A higher score indicates participants are uncomfortable with sharing of in-home sensor monitoring data. * 4 questions about the participants experience with in-home sensor monitoring, the participant can choose from 1 = strongly agree to 5 = strongly disagree. A lower score indicates that the participant feels like in-home sensor monitoring interferes with their daily activities.
Changes in gait speed of .1m/s or more (Arm A only)
时间窗: 6 months
Stride length (Arm A only)
时间窗: 6 months
Number of grade ≥3 adverse events measured by CTCAE (Arm A only)
时间窗: 6 months
Patient reported outcomes of 10 common symptoms (Arm A)
时间窗: 6 months
* The reported symptoms are decreased appetite, pain, decreased activity level, depressed mood, nausea, vomiting, diarrhea, constipation, shortness of breath, and insomnia * Patient reports on a scale of 1-5 with 1 indicating the symptom is absent and 5 indicating the symptom is severe
Reason for not choosing in-home monitoring as measured by a modified version of the Intelligent Systems for Assessment of Aging Changes Technology Survey (Arm B only)
时间窗: At the time of invitation to participate in the study (Day 1)
* 11 questions about how the participant would feel about in-home sensor monitoring, the participant can choose from 1 = strongly agree to 5 = strongly disagree. A higher score means that the participant that does not feel comfortable with in-home sensor monitoring * 2 questions about concerns about information gathered by the in-home sensor monitoring might be shared, answers range from 1 = very concerned to 4 = not concerned at all. A higher score indicates participants are uncomfortable with sharing of in-home sensor monitoring data.
次要结局
未报告次要终点