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Clinical Trials/NCT04306783
NCT04306783
Withdrawn
N/A

In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study

ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
Washington University School of Medicine
Primary Endpoint
Number of Hospitalizations (Arm A only)
Status
Withdrawn
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2020
End Date
April 30, 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Number of Hospitalizations (Arm A only)

Time Frame: 6 months

Number of Emergency room visits (Arm A only)

Time Frame: 6 months

Number of Falls (Arm A only)

Time Frame: 6 months

Heart rate (Arm A only)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 6 months

Stride length (Arm A only)

Time Frame: 6 months

Number of grade ≥3 adverse events measured by CTCAE (Arm A only)

Time Frame: 6 months

Patient reported outcomes of 10 common symptoms (Arm A)

Time Frame: 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)

Time Frame: 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.

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