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In-Home Sensor Monitoring of Older Adults With Cancer

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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Recruitment Status : Withdrawn (Investigator is leaving the university)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

Tracking Information
First Submitted Date  ICMJE November 5, 2019
First Posted Date  ICMJE March 13, 2020
Last Update Posted Date September 16, 2020
Estimated Study Start Date  ICMJE October 31, 2020
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
  • 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.
  • Heart rate (Arm A only) [ Time Frame: 6 months ]
    -A meaningful change is heart rate outside the normal range of 60-100
  • 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 Falls (Arm A only) [ Time Frame: 6 months ]
  • Number of Hospitalizations (Arm A only) [ Time Frame: 6 months ]
  • Number of Emergency room visits (Arm A only) [ Time Frame: 6 months ]
  • Number of Infections requiring medical intervention (e.g. oral antibiotics) (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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE In-Home Sensor Monitoring of Older Adults With Cancer
Official Title  ICMJE In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE Other: In-home sensor monitoring
-Installed and maintained by Foresite Healthcare
Study Arms  ICMJE
  • 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.
    Intervention: Other: In-home sensor monitoring
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 14, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 9, 2020)
120
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT04306783
Other Study ID Numbers  ICMJE 202001189
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Institute of Clinical and Translational Sciences
Investigators  ICMJE
Principal Investigator: Tanya M Wildes, M.D., MSCI Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP