ECM and Monitoring w/ Alio Smart Patch in Cancer Pts Receiving Chemotherapy
ConditionFebrile Neutropenia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCase Comprehensive Cancer Center
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Subjects have a diagnosis of soft tissue sarcoma, NSCLC, HNSCC, breast, pancreatic cancer, or melanoma
Age > or equal to 65 years
Advanced disease
Previous Chemotherapy or Radiation therapy
Disqualifiers
Participants who cannot read or speak English
Participants without any cellphone access
Trial design
Design model
Single group
Treatments tested in this trial
Alio Smart Patch™
DeviceAlio 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Remote Monitoring with SmartpatchExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Participant compliance
Rate of participant compliance will be measured. Alio Smartpatch Compliance is defined as \>=80% daily use, reflecting participant adherence to the prescribed monitoring regimen.
Time frame
Up to 12 weeks from entering studySecondary outcomes
1
Identification of febrile neutropenia symptoms
Success rate of Alio Smart Patch under QRC ECM ability to identify febrile neutropenia symptoms.
Time frame
Up to 13 weeks from entering study2
Participant satisfaction: Usability
The average participant satisfaction score will be measured by assessing participant satisfaction concerning the usability of Alio Smart Patch under QRC ECM.
Time frame
Up to 13 weeks from entering study3
Participant satisfaction: Comfort
The average participant satisfaction score will be measured by assessing participant satisfaction concerning the comfort of using Alio Smart Patch under QRC ECM.
Time frame
Up to 13 weeks from entering study4
Participant satisfaction: Overall Experience
The average participant satisfaction score will be measured by assessing participant satisfaction concerning the overall experience of using Alio Smart Patch under QRC ECM.
Time frame
Up to 13 weeks from entering studySponsors and contacts
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Source ClinicalTrials.gov