Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06657183

Enhanced Care Management and Continuous Monitoring With Alio Smart Patch in Adult Cancer Patients Receiving Chemotherapy or Immunotherapy at Risk of Febrile Neutropenia

Led by Case Comprehensive Cancer Center · Updated on 2026-05-08

30

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate a remote monitoring program designed for adult cancer patients receiving chemotherapy or immunotherapy, particularly those at moderate or high risk of febrile neutropenia or related complications. The study focuses on early detection and management of treatment side effects by continuously tracking vital signs and blood levels to reduce emergency visits and hospital admissions. The program uses advanced wearable technology to provide real-time physiological and biochemical data to healthcare providers. Participants will wear the Alio Smart Patch, a non-invasive biosensor that continuously measures vital signs, hematologic, and electrolyte data. They will also use continuous glucose monitors to track glucose levels. This data is remotely monitored by clinical staff from Quantify Remote Care, who will contact participants promptly if signs of side effects or complications arise. The program also offers dietary and mental health support as needed. The study period lasts up to 13 weeks, during which participants receive continuous monitoring and support. Throughout the study, researchers will assess participant compliance with wearing the devices, usability and comfort, and overall satisfaction. They will also track clinical outcomes such as the identification of febrile neutropenia symptoms and the effectiveness of early detection in reducing emergency care visits. Data collected will support better clinical decisions while participants continue their regular cancer treatment. The total participation duration extends up to 13 weeks from enrollment, with close monitoring by the study team.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of soft tissue sarcoma, NSCLC, HNSCC, breast, pancreatic cancer, or melanoma
  • Starting a new chemotherapy regimen with high or intermediate risk of febrile neutropenia or starting immunotherapy alone or with chemotherapy
  • Able to give informed consent
  • Able to read and/or speak English
  • Age between 18 and 65 years
  • Expected chemotherapy treatment duration of at least 12 weeks
Not Eligible

You will not qualify if you...

  • Cannot read or speak English
  • No access to a cellphone

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Implementation

Duration - Up to 12 weeks

Participants wear the Alio Smart Patch device continuously to provide real-time physiological, hematologic, and electrolyte data to healthcare providers for early detection of chemotherapy-related toxicities and complications.

Continuous remote monitoring with periodic remote data syncs; minimal in-person visits as needed

Follow-up

Duration - Up to 1 additional week after implementation

Participants are monitored for an additional period to assess compliance, participant satisfaction, and clinical effectiveness of the monitoring system in early detection and reducing emergency care visits.

1 to 2 follow-up visits (in-person or remote) depending on participant status

Trial Site Locations

Total: 1 location

1

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

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Research Team

A

Alberto Montero, MD, MBA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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