Clinical trial NCT04306783: In-Home Sensor Monitoring of Older Adults With Cancer
Official title: In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Institute of Clinical and Translational Sciences
First posted: 2020-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 6 months
measure: Heart rate (Arm A only)
timeFrame: 6 months
measure: Changes in gait speed of .1m/s or more (Arm A only)
timeFrame: 6 months
measure: Stride length (Arm A only)
timeFrame: 6 months
measure: Number of Falls (Arm A only)
timeFrame: 6 months
measure: Number of Hospitalizations (Arm A only)
timeFrame: 6 months
measure: Number of Emergency room visits (Arm A only)
timeFrame: 6 months
measure: Number of Infections requiring medical intervention (e.g. oral antibiotics) (Arm A only)
timeFrame: 6 months
measure: Number of grade ≥3 adverse events measured by CTCAE (Arm A only)
timeFrame: 6 months
measure: Patient reported outcomes of 10 common symptoms (Arm A)
timeFrame: 6 months
measure: 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)
timeFrame: At the time of invitation to participate in the study (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Tanya M Wildes, M.D., MSCI
role: PRINCIPAL_INVESTIGATOR
References: