CancerNCT04306783
In-Home Sensor Monitoring of Older Adults With Cancer
A study testing In-home sensor monitoring in people with Cancer, run by Washington University School of Medicine.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- In-home sensor monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2020to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
About this study
Official title: In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study
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
- Being tested
- In-home sensor monitoring
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-home sensor monitoringOther
-Installed and maintained by Foresite Healthcare
| Study group | Role | What they receive |
|---|---|---|
| Arm A: In-Home Sensor Monitoring | Experimental | 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. Receives: Other: In-home sensor monitoring |
| Arm B: Survey Only | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Heart rate (Arm A only)
-A meaningful change is heart rate outside the normal range of 60-100
Measured: 6 months
Changes in gait speed of .1m/s or more (Arm A only)
Measured: 6 months
Stride length (Arm A only)
Measured: 6 months
Number of Falls (Arm A only)
Measured: 6 months
Number of Hospitalizations (Arm A only)
Measured: 6 months
Number of Emergency room visits (Arm A only)
Measured: 6 months
Number of Infections requiring medical intervention (e.g. oral antibiotics) (Arm A only)
Measured: 6 months
Number of grade ≥3 adverse events measured by CTCAE (Arm A only)
Measured: 6 months
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
Measured: 6 months
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.
Measured: At the time of invitation to participate in the study (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start31 Oct 2020 (estimated)
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Why it stopped: Investigator is leaving the university
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Clinical and Translational Sciences
- Responsible party
- Sponsor
- Investigators
- Tanya M Wildes, M.D., MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306783
- Sponsor's protocol ID
- 202001189
- Status last verified
- Sep 2020
- First submitted
- 5 Nov 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Home Sensor Monitoring of Older Adults With Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT04306783
- Acronym / sponsor ID
- 202001189
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator is leaving the university
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Institute of Clinical and Translational Sciences
- Study start
- 31 Oct 2020 (estimated)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 13 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: In-Home Sensor Monitoring | Experimental | Other: In-home sensor monitoringOlder 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. |
| Arm B: Survey Only | No intervention | –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 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
- Inability to read and understand English
- Only receiving hormonal agents (e.g. anti-estrogen or anti-androgen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-home sensor monitoring-Installed and maintained by Foresite Healthcare | Other | Arm A: In-Home Sensor Monitoring |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanya M Wildes, M.D., MSCI principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing In-home sensor monitoring in people with Cancer, run by Washington University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.