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

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

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

Conditions2

Locations1 site

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