Febrile NeutropeniaNCT06657183
ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy
A study testing Alio Smart Patch™ in people with Febrile Neutropenia, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
Undergoing cancer treatment comes with various risks and side effects. This clinical trial aims to reduce those risks and side effects through continuous monitoring of vital signs and blood levels. The goal is to see if potential side effects can be identified and treated sooner. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- Alio Smart Patch™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2025to 16 Jun 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Subjects have a diagnosis of soft tissue sarcoma, NSCLC, HNSCC, breast, pancreatic cancer, or melanoma
- For Cohort 1 (n=15), participants are eligible if starting on a new chemotherapy regimen with either: (i) high risk (> 20%) of febrile neutropenia as per NCCN MGF guidelines; or (ii) intermediate risk for febrile neutropenia AND one or more risk factors for febrile neutropenia:
- Age > or equal to 65 years
- Advanced disease
- Previous Chemotherapy or Radiation therapy
Show all 21Show fewer
- Preexisting neutropenia or bone marrow involvement with tumor
- Infection
- Open wounds or surgery in last 4 weeks
- Poor performance status or poor nutritional status
- Poor renal function (cr clearance <50)
- Total Bilirubin >1.5 upper limit of normal
- Cardiovascular Disease
- Multiple Co-morbidities
- HIV infection
- BMI > 2.0
- For Cohort 2 (n=15) participants are eligible if starting on immunotherapy alone, or concurrent chemo-immunotherapy.
- Participants are capable of giving informed consent
- Participants must be able to read and/or to speak English
- Participants who are 18 years of age or older
- Expected chemotherapy treatment duration of at least 12 weeks
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Participants who cannot read or speak English
- Participants without any cellphone access
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center
Cleveland, Ohio, 44106
About this study
Official title: Enhanced Care Management (ECM) and Continuous Monitoring of Vital Signs With Alio Smart Patch Wearable Sensor in Adult Cancer Patients Receiving Chemotherapy With Moderate or High Risk of Febrile Neutropenia or Immunotherapy
Undergoing cancer treatment comes with various risks and side effects. This clinical trial aims to reduce those risks and side effects through continuous monitoring of vital signs and blood levels. The goal is to see if potential side effects can be identified and treated sooner.
During this study, participants will wear an Alio Smartpatch™. The Alio Smartpatch™ is a wireless remote monitoring system. This device will measure participants' vital signs and blood levels. Participants will also be asked to use continuous glucose monitors to measure their glucose levels. The data collected on each participant from these devices will be remotely monitored at all times by clinical staff at a company known as Quantify Remote Care. If a participant's results look like they are experiencing a side effect, the participant will be contacted immediately by Quantify Remote Care team. The Quantify Remote Care team will function as an extension of the participant's cancer clinical team and will relay any significant issues back to them. Quantify Health also provides dietary and mental health support as needed for all participants.
Read the detailed description
Cancer care often involves aggressive treatments like chemotherapy, exposing patients to serious risks, such as febrile neutropenia, and other chemotherapy-related complications. Current care models depend heavily on patients reporting issues, often leading to delays in necessary intervention. This emphasizes the need for a more proactive and sophisticated approach to patient monitoring and care management. Modern wearable devices provide continuous objective data with the goal of enhancing cancer care. Patient-generated health data (PGHD), or health-related data gathered from patients to help address a health concern, are used increasingly in oncology to make regulatory decisions and evaluate quality of care. PGHD include self-reported health and treatment histories and patient-reported outcomes (PROs). A recent prospective study assessed the feasibility of monitoring of physical activity using a commercial wearable device and collecting electronic patient-reported outcomes (ePROs) during radiotherapy (RT) for head and neck cancer (HNC). In this study 29 patients were enrolled; step data were recorded on 70% of the days during patients' RT courses, and there were only 11 patients (38%) for whom step data were collected on at least 80% of days during RT. feasibility end point was not achieved suggesting that rigorous workflows are required to achieve continuous activity monitoring during RT. However, the findings are consistent with previous reports indicating that wearable device data can help identify patients who are at risk for unplanned hospitalization. In another study, patients with early stage breast cancer were enrolled prior to starting chemotherapy. Patients received a Fitbit Charge HR and were instructed to wear it and sync at least weekly throughout chemotherapy and up to six months post therapy. Patients completed baseline surveys, and treatment information was collected from their medical records. Fitbit data was downloaded from the Fitabase data management platform. To assess utility, they evaluated how many days patients wore their Fitbit for at least 10 hours. Fitbit use during breast cancer chemotherapy was poor in the absence of prompts to encourage wear. Interventions including phone calls, texts, to maintain adherence are likely necessary to increase wear in active treatment settings. Cancer patients receiving chemotherapy who are at high risk of febrile neutropenia, infections or complications in general, would benefit from a new remote monitoring model that not only monitors data but records, trends and delivers actionable clinical insights regarding the patient status with a goal of intervening early and evaluate potential toxicities and complications from treatment. The goal would be to assess compliance in addition to decrease frequency of emergency department visits as well as unplanned hospital admissions.
Quantify Remote Care's Enhanced Care Management (ECM) program aims to proactively manage patients undergoing complex treatment regimens, particularly those at high risk for complications. Our ECM program harnesses cutting-edge technology to enable continuous, real-time monitoring of a variety of physiological metrics, allowing for immediate intervention at the earliest signs of patient distress. One such technology is the Alio Smart Patch, originally developed for monitoring patients with end-stage renal disease undergoing hemodialysis. The wearable biosensor offers multi-sensor capabilities, capturing physiologic, hematologic, and electrolyte data in real time. This data is then channeled into a provider-based portal for seamless integration into clinical decision-making processes.
This pilot study aims to evaluate the efficacy of Quantify Remote Care's ECM program in cancer patients receiving chemotherapy, who are notably at higher risk of complications from treatment. Participants will be equipped with the Alio Smart Patch, giving healthcare providers 24-hour access to essential medical data, thereby enabling timely interventions to prevent severe complications.
- Conditions
- Febrile Neutropenia
- Being tested
- Alio Smart Patch™
- Keywords
- Alio Smart Patch
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alio Smart Patch™Device
Alio Smart Patch is a non-invasive wearable biosensor that combines a unique, multi-sensor, wearable device with a provided- based portal to track sequentially the participant's physiologic, hematologic and electrolyte data. It works in conjunction with a home hub data relay system and an end-to-end cloud software data path. The system has been developed to enable home monitoring for multiple key metrics by healthcare provider caring for participants.
Enhanced Care Management (ECM) is a comprehensive, system-centric approach crafted to bridge the latent gaps in traditional care paradigms. ECM provides an exhaustive review of a participant's medical history and their personalized social needs, addressing both in a cohesive, participant-focused strategy.
This intervention couples Quantify Remote Care's Enhanced Care Management with the Alio Smart Patch technology.
| Study group | Role | What they receive |
|---|---|---|
| Remote Monitoring with Smartpatch | Experimental | Participants will be continuously monitored through the device, providing crucial physiological data. The Smartpatch will allow for early detection of chemotherapy-related toxicities. Receives: Device: Alio Smart Patch™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant compliance
Rate of participant compliance will be measured. Alio Smartpatch Compliance is defined as >=80% daily use, reflecting participant adherence to the prescribed monitoring regimen.
Measured: Up to 12 weeks from entering study
Secondary outcomes (6)
Identification of febrile neutropenia symptoms
Success rate of Alio Smart Patch under QRC ECM ability to identify febrile neutropenia symptoms.
Measured: Up to 13 weeks from entering study
Participant satisfaction: Usability
The average participant satisfaction score will be measured by assessing participant satisfaction concerning the usability of Alio Smart Patch under QRC ECM.
Measured: Up to 13 weeks from entering study
Participant satisfaction: Comfort
The average participant satisfaction score will be measured by assessing participant satisfaction concerning the comfort of using Alio Smart Patch under QRC ECM.
Measured: Up to 13 weeks from entering study
Participant satisfaction: Overall Experience
The average participant satisfaction score will be measured by assessing participant satisfaction concerning the overall experience of using Alio Smart Patch under QRC ECM.
Measured: Up to 13 weeks from entering study
Clinical effectiveness of the integrated QRC ECM and smartpatch as measured by frequency of emergency care
To validate the clinical effectiveness of the QRC ECM with smartpatch method, metrics will include the number of emergency room visits to determine if there is a reduction.
Measured: Up to 13 weeks from entering study
Clinical effectiveness of the integrated QRC ECM and smartpatch as measured by early detection
To validate the clinical effectiveness of the QRC ECM with smartpatch method, metrics will include the rate of early detection.
Measured: Up to 13 weeks from entering study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start6 Aug 2025
- Primary completion28 Apr 2026
- Study completion16 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melinda Hsu, MD, Principal investigator, Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657183
- Sponsor's protocol ID
- CASE4124
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2024
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a pilot study
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Care Management (ECM) and Continuous Monitoring of Vital Signs With Alio Smart Patch Wearable Sensor in Adult Cancer Patients Receiving Chemotherapy With Moderate or High Risk of Febrile Neutropenia or Immunotherapy
- ClinicalTrials.gov ID
- NCT06657183
- Acronym / sponsor ID
- CASE4124
- Conditions
- Febrile Neutropenia
- Keywords
- Alio Smart Patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 16 Jun 2026 (actual)
- First posted
- 24 Oct 2024 (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.
Undergoing cancer treatment comes with various risks and side effects. This clinical trial aims to reduce those risks and side effects through continuous monitoring of vital signs and blood levels. The goal is to see if potential side effects can be identified and treated sooner.
During this study, participants will wear an Alio Smartpatch™. The Alio Smartpatch™ is a wireless remote monitoring system. This device will measure participants' vital signs and blood levels. Participants will also be asked to use continuous glucose monitors to measure their glucose levels. The data collected on each participant from these devices will be remotely monitored at all times by clinical staff at a company known as Quantify Remote Care. If a participant's results look like they are experiencing a side effect, the participant will be contacted immediately by Quantify Remote Care team. The Quantify Remote Care team will function as an extension of the participant's cancer clinical team and will relay any significant issues back to them. Quantify Health also provides dietary and mental health support as needed for all participants.
Detailed description
Cancer care often involves aggressive treatments like chemotherapy, exposing patients to serious risks, such as febrile neutropenia, and other chemotherapy-related complications. Current care models depend heavily on patients reporting issues, often leading to delays in necessary intervention. This emphasizes the need for a more proactive and sophisticated approach to patient monitoring and care management. Modern wearable devices provide continuous objective data with the goal of enhancing cancer care. Patient-generated health data (PGHD), or health-related data gathered from patients to help address a health concern, are used increasingly in oncology to make regulatory decisions and evaluate quality of care. PGHD include self-reported health and treatment histories and patient-reported outcomes (PROs). A recent prospective study assessed the feasibility of monitoring of physical activity using a commercial wearable device and collecting electronic patient-reported outcomes (ePROs) during radiotherapy (RT) for head and neck cancer (HNC). In this study 29 patients were enrolled; step data were recorded on 70% of the days during patients' RT courses, and there were only 11 patients (38%) for whom step data were collected on at least 80% of days during RT. feasibility end point was not achieved suggesting that rigorous workflows are required to achieve continuous activity monitoring during RT. However, the findings are consistent with previous reports indicating that wearable device data can help identify patients who are at risk for unplanned hospitalization. In another study, patients with early stage breast cancer were enrolled prior to starting chemotherapy. Patients received a Fitbit Charge HR and were instructed to wear it and sync at least weekly throughout chemotherapy and up to six months post therapy. Patients completed baseline surveys, and treatment information was collected from their medical records. Fitbit data was downloaded from the Fitabase data management platform. To assess utility, they evaluated how many days patients wore their Fitbit for at least 10 hours. Fitbit use during breast cancer chemotherapy was poor in the absence of prompts to encourage wear. Interventions including phone calls, texts, to maintain adherence are likely necessary to increase wear in active treatment settings. Cancer patients receiving chemotherapy who are at high risk of febrile neutropenia, infections or complications in general, would benefit from a new remote monitoring model that not only monitors data but records, trends and delivers actionable clinical insights regarding the patient status with a goal of intervening early and evaluate potential toxicities and complications from treatment. The goal would be to assess compliance in addition to decrease frequency of emergency department visits as well as unplanned hospital admissions.
Quantify Remote Care's Enhanced Care Management (ECM) program aims to proactively manage patients undergoing complex treatment regimens, particularly those at high risk for complications. Our ECM program harnesses cutting-edge technology to enable continuous, real-time monitoring of a variety of physiological metrics, allowing for immediate intervention at the earliest signs of patient distress. One such technology is the Alio Smart Patch, originally developed for monitoring patients with end-stage renal disease undergoing hemodialysis. The wearable biosensor offers multi-sensor capabilities, capturing physiologic, hematologic, and electrolyte data in real time. This data is then channeled into a provider-based portal for seamless integration into clinical decision-making processes.
This pilot study aims to evaluate the efficacy of Quantify Remote Care's ECM program in cancer patients receiving chemotherapy, who are notably at higher risk of complications from treatment. Participants will be equipped with the Alio Smart Patch, giving healthcare providers 24-hour access to essential medical data, thereby enabling timely interventions to prevent severe complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remote Monitoring with Smartpatch | Experimental | Device: Alio Smart Patch™Participants will be continuously monitored through the device, providing crucial physiological data. The Smartpatch will allow for early detection of chemotherapy-related toxicities. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
- Subjects have a diagnosis of soft tissue sarcoma, NSCLC, HNSCC, breast, pancreatic cancer, or melanoma
- For Cohort 1 (n=15), participants are eligible if starting on a new chemotherapy regimen with either: (i) high risk (> 20%) of febrile neutropenia as per NCCN MGF guidelines; or (ii) intermediate risk for febrile neutropenia AND one or more risk factors for febrile neutropenia:
- For Cohort 2 (n=15) participants are eligible if starting on immunotherapy alone, or concurrent chemo-immunotherapy.
- Participants are capable of giving informed consent
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
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 |
|---|---|---|
| Alio Smart Patch™Alio Smart Patch is a non-invasive wearable biosensor that combines a unique, multi-sensor, wearable device with a provided- based portal to track sequentially the participant's physiologic, hematologic and electrolyte data. It works in conjunction with a home hub data relay system and an end-to-end cloud software data path. The system has been developed to enable home monitoring for multiple key metrics by healthcare provider caring for participants. Enhanced Care Management (ECM) is a comprehensive, system-centric approach crafted to bridge the latent gaps in traditional care paradigms. ECM provides an exhaustive review of a participant's medical history and their personalized social needs, addressing both in a cohesive, participant-focused strategy. This intervention couples Quantify Remote Care's Enhanced Care Management with the Alio Smart Patch technology. | Device | Remote Monitoring with Smartpatch |
Primary outcome
Participant compliance
Time frame: Up to 12 weeks from entering study
Rate of participant compliance will be measured. Alio Smartpatch Compliance is defined as >=80% daily use, reflecting participant adherence to the prescribed monitoring regimen.
6 secondary outcomes
Identification of febrile neutropenia symptoms
Time frame: Up to 13 weeks from entering study
Participant satisfaction: Usability
Time frame: Up to 13 weeks from entering study
Participant satisfaction: Comfort
Time frame: Up to 13 weeks from entering study
Participant satisfaction: Overall Experience
Time frame: Up to 13 weeks from entering study
Clinical effectiveness of the integrated QRC ECM and smartpatch as measured by frequency of emergency care
Time frame: Up to 13 weeks from entering study
Clinical effectiveness of the integrated QRC ECM and smartpatch as measured by early detection
Time frame: Up to 13 weeks from entering study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No. This is a pilot study
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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.
Melinda Hsu, MD principal investigator
Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alio Smart Patch™ in people with Febrile Neutropenia, run by Case Comprehensive Cancer Center at 1 site in United States.
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 21 inclusion and 3 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: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant compliance (time frame: Up to 12 weeks from entering study). 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 24 Jul 2026.