In-Home Sensor Monitoring of Older Adults With Cancer

NCT ID: NCT04306783

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-31
• Study Completion Date: 2022-04-30

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.

Conditions

Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arm A: In-Home Sensor Monitoring

Older adults with cancer undergoing systemic cancer treatment will undergo passive monitoring with motion sensors and bed sensor. Passive infrared (PIR) motion sensors will be installed in their homes to detect presence in a particular room (e.g., bathroom or kitchen) as well as for specific activities. There will also be a bed sensor, which is a pneumatic strip installed under the bed linens, which measures displacement of the resident's upper torso as he or she lies on the bed. Participants will complete a baseline primarily self-administered survey, an abbreviated assessment with each follow up clinic visit (at least once per month) for 6 months of follow up and a final end of study assessment.

Group Type: EXPERIMENTAL

In-home sensor monitoring

Intervention Type: OTHER

-Installed and maintained by Foresite Healthcare

Arm B: Survey Only

Patients that choose to not proceed with in-home sensor monitoring will be asked to complete a brief survey that explores attitudes regarding in-home sensor monitoring

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

In-home sensor monitoring

-Installed and maintained by Foresite Healthcare

Intervention Type: OTHER

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Clinical and Translational Sciences

UNKNOWN

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tanya M Wildes, M.D., MSCI

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Related Links

http://www.siteman.wustl.edu

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

Other Identifiers

202001189

Identifier Type: -

Identifier Source: org_study_id