Cancer
Conditions
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.
Interventions
OTHERIn-home sensor monitoring
-Installed and maintained by Foresite Healthcare
Sponsors
Institute of Clinical and Translational Sciences
Washington University School of Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | 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) | 6 months | — |
| Stride length (Arm A only) | 6 months | — |
| Number of Falls (Arm A only) | 6 months | — |
| Number of Hospitalizations (Arm A only) | 6 months | — |
| Number of Emergency room visits (Arm A only) | 6 months | — |
| Number of Infections requiring medical intervention (e.g. oral antibiotics) (Arm A only) | 6 months | — |
| Number of grade ≥3 adverse events measured by CTCAE (Arm A only) | 6 months | — |
| Patient reported outcomes of 10 common symptoms (Arm A) | 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) | 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. |
Outcome results
None listed