RECRUITING

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

Talk to us

Conditions

Febrile NeutropeniaAlio Smart Patch

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-08-06
Study Completion:2026-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06657183

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:
  2. * Subjects have a diagnosis of soft tissue sarcoma, NSCLC, HNSCC, breast, pancreatic cancer, or melanoma
  3. * 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:
  4. * Age \> or equal to 65 years
  5. * Advanced disease
  6. * Previous Chemotherapy or Radiation therapy
  7. * Preexisting neutropenia or bone marrow involvement with tumor
  8. * Infection
  9. * Open wounds or surgery in last 4 weeks
  10. * Poor performance status or poor nutritional status
  11. * Poor renal function (cr clearance \<50)
  12. * Total Bilirubin \>1.5 upper limit of normal
  13. * Cardiovascular Disease
  14. * Multiple Co-morbidities
  15. * HIV infection
  16. * BMI \> 2.0
  17. * For Cohort 2 (n=15) participants are eligible if starting on immunotherapy alone, or concurrent chemo-immunotherapy.
  18. * Participants are capable of giving informed consent
  19. * Participants must be able to read and/or to speak English
  20. * Participants who are 18 years of age or older
  21. * Expected chemotherapy treatment duration of at least 12 weeks
  1. * An individual who meets any of the following criteria will be excluded from participation in this study:
  2. * Participants who cannot read or speak English
  3. * Participants without any cellphone access

Contacts and Locations

Study Contact

Alberto Montero, MD, MBA
CONTACT
216-844-3951
Alberto.Montero@UHhospitals.org

Principal Investigator

Alberto Montero, MD, MBA
PRINCIPAL_INVESTIGATOR
Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center

Study Locations (Sites)

Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center Seidman Cancer Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Alberto Montero, MD, MBA, PRINCIPAL_INVESTIGATOR, Case Comprehensive Cancer Center, University Hospitals Seidman Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-06
Study Completion Date2026-10

Study Record Updates

Study Start Date2025-08-06
Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

  • Alio Smart Patch

Additional Relevant MeSH Terms

  • Febrile Neutropenia