In-Home Sensor Monitoring of Older Adults With Cancer

Not Applicable

Withdrawn

• Conditions: Cancer

• Registration Number: NCT04306783
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-13
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-14
• Last Update Posted: 2020-09-16
• Study Start: 2020-10-31
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Arm A:

• Age ≥ 65
• 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

Arm B:

• Age ≥ 65
• 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

Exclusion Criteria

Arm A:

• 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

Arm B:

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Falls (Arm A only)	6 months
Heart rate (Arm A only)	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)	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)	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)	6 months
Stride length (Arm A only)	6 months
Number of Hospitalizations (Arm A only)	6 months
Number of Emergency room visits (Arm A only)	6 months
Number of grade ≥3 adverse events measured by CTCAE (Arm A only)	6 months
Patient reported outcomes of 10 common symptoms (Arm A)	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)	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.