Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06657183
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
ECM and Monitoring w Alio Smart Patch in Cancer Pts Receiving Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 participants 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 participants 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
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 participants 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 participants 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
Detailed 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 address a health concern are used increasingly in oncology to make regulatory decisions and evaluate quality of care PGHD include self-reported health and treatment histories and patient-reported outcomes PROs A recent prospective study assessed the feasibility of monitoring of physical activity using a commercial wearable device and collecting electronic patient-reported outcomes ePROs during radiotherapy RT for head and neck cancer HNC In this study 29 patients were enrolled step data were recorded on 70 of the days during patients RT courses and there were only 11 patients 38 for whom step data were collected on at least 80 of days during RT feasibility end point was not achieved suggesting that rigorous workflows are required to achieve continuous activity monitoring during RT However the findings are consistent with previous reports indicating that wearable device data can help identify patients who are at risk for unplanned hospitalization In another study patients with early stage breast cancer were enrolled prior to starting chemotherapy Patients received a Fitbit Charge HR and were instructed to wear it and sync at least weekly throughout chemotherapy and up to six months post therapy Patients completed baseline surveys and treatment information was collected from their medical records Fitbit data was downloaded from the Fitabase data management platform To assess utility they evaluated how many days patients wore their Fitbit for at least 10 hours Fitbit use during breast cancer chemotherapy was poor in the absence of prompts to encourage wear Interventions including phone calls texts to maintain adherence are likely necessary to increase wear in active treatment settings Cancer patients receiving chemotherapy who are at high risk of febrile neutropenia infections or complications in general would benefit from a new remote monitoring model that not only monitors data but records trends and delivers actionable clinical insights regarding the patient status with a goal of intervening early and evaluate potential toxicities and complications from treatment The goal would be to assess compliance in addition to decrease frequency of emergency department visits as well as unplanned hospital admissions
Quantify Remote Cares Enhanced Care Management ECM program aims to proactively manage patients undergoing complex treatment regimens particularly those at high risk for complications Our ECM program harnesses cutting-edge technology to enable continuous real-time monitoring of a variety of physiological metrics allowing for immediate intervention at the earliest signs of patient distress One such technology is the Alio Smart Patch originally developed for monitoring patients with end-stage renal disease undergoing hemodialysis The wearable biosensor offers multi-sensor capabilities capturing physiologic hematologic and electrolyte data in real time This data is then channeled into a provider-based portal for seamless integration into clinical decision-making processes
This pilot study aims to evaluate the efficacy of Quantify Remote Cares ECM program in cancer patients receiving chemotherapy who are notably at higher risk of complications from treatment Participants will be equipped with the Alio Smart Patch giving healthcare providers 24-hour access to essential medical data thereby enabling timely interventions to prevent severe complications
Quantify Remote Cares Enhanced Care Management ECM program aims to proactively manage patients undergoing complex treatment regimens particularly those at high risk for complications Our ECM program harnesses cutting-edge technology to enable continuous real-time monitoring of a variety of physiological metrics allowing for immediate intervention at the earliest signs of patient distress One such technology is the Alio Smart Patch originally developed for monitoring patients with end-stage renal disease undergoing hemodialysis The wearable biosensor offers multi-sensor capabilities capturing physiologic hematologic and electrolyte data in real time This data is then channeled into a provider-based portal for seamless integration into clinical decision-making processes
This pilot study aims to evaluate the efficacy of Quantify Remote Cares ECM program in cancer patients receiving chemotherapy who are notably at higher risk of complications from treatment Participants will be equipped with the Alio Smart Patch giving healthcare providers 24-hour access to essential medical data thereby enabling timely interventions to prevent severe complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None