RecruitingNot ApplicableNCT06657183

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

Sponsor

Case Comprehensive Cancer Center

Enrollment

30 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

Febrile Neutropenia

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. 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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria20

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 Criteria3

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

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Interventions

DEVICEAlio 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.