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
Case Comprehensive Cancer Center
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.
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…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 Chemothe…
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.
Location
- Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer CenterCleveland, Ohio