ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Febrile Neutropenia
• Intervention / Treatment: Device: Alio Smart Patch™

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alberto Montero, MD, MBA; Phone Number: 216-844-3951; Email: Alberto.Montero@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center
      • Contact: Alberto Montero, MD, MBA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
  • 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Remote Monitoring with Smartpatch; Participants will be continuously monitored through the device, providing crucial physiological data. The Smartpatch will allow for early detection of chemotherapy-related toxicities.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 weeks from entering study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of febrile neutropenia symptoms	Success rate of Alio Smart Patch under QRC ECM ability to identify febrile neutropenia symptoms.	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.	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.	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.	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.	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.	Up to 13 weeks from entering study

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Alberto Montero, MD, MBA, Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: October 17, 2024
• First Submitted That Met QC Criteria: October 23, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Alio Smart Patch
• Additional Relevant MeSH Terms: Cytopenia; Leukocyte Disorders; Hematologic Diseases; Leukopenia; Agranulocytosis; Neutropenia; Hemic and Lymphatic Diseases; Febrile Neutropenia
• Other Study ID Numbers: CASE4124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a pilot study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes