In-Home Sensor Monitoring of Older Adults With Cancer

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04306783
• Other study ID #: 202001189
• Status: Withdrawn
• Phase: N/A
• Start date: October 31, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: September 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• In-home sensor monitoring
-Installed and maintained by Foresite Healthcare

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Institute of Clinical and Translational Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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.	6 months
Primary	Heart rate (Arm A only)	-A meaningful change is heart rate outside the normal range of 60-100	6 months
Primary	Changes in gait speed of .1m/s or more (Arm A only)		6 months
Primary	Stride length (Arm A only)		6 months
Primary	Number of Falls (Arm A only)		6 months
Primary	Number of Hospitalizations (Arm A only)		6 months
Primary	Number of Emergency room visits (Arm A only)		6 months
Primary	Number of Infections requiring medical intervention (e.g. oral antibiotics) (Arm A only)		6 months
Primary	Number of grade =3 adverse events measured by CTCAE (Arm A only)		6 months
Primary	Patient reported outcomes of 10 common symptoms (Arm A)	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	6 months
Primary	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)	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.	At the time of invitation to participate in the study (Day 1)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine