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In-Home Sensor Monitoring of Older Adults With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04306783
Recruitment Status : Withdrawn (Investigator is leaving the university)
First Posted : March 13, 2020
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
Institute of Clinical and Translational Sciences
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cancer Other: In-home sensor monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study
Estimated Study Start Date : October 31, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022

Arm Intervention/treatment
Experimental: 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.
Other: In-home sensor monitoring
-Installed and maintained by Foresite Healthcare

No Intervention: 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



Primary Outcome Measures :
  1. 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.

  2. Heart rate (Arm A only) [ Time Frame: 6 months ]
    -A meaningful change is heart rate outside the normal range of 60-100

  3. Changes in gait speed of .1m/s or more (Arm A only) [ Time Frame: 6 months ]
  4. Stride length (Arm A only) [ Time Frame: 6 months ]
  5. Number of Falls (Arm A only) [ Time Frame: 6 months ]
  6. Number of Hospitalizations (Arm A only) [ Time Frame: 6 months ]
  7. Number of Emergency room visits (Arm A only) [ Time Frame: 6 months ]
  8. Number of Infections requiring medical intervention (e.g. oral antibiotics) (Arm A only) [ Time Frame: 6 months ]
  9. Number of grade ≥3 adverse events measured by CTCAE (Arm A only) [ Time Frame: 6 months ]
  10. 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

  11. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04306783


Sponsors and Collaborators
Washington University School of Medicine
Institute of Clinical and Translational Sciences
Investigators
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Principal Investigator: Tanya M Wildes, M.D., MSCI Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04306783    
Other Study ID Numbers: 202001189
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No