Remote Monitoring in Cancer Care: A Platform Study

Status Recruiting

Clinical Trial Summary

This study investigates a device that closely monitors vital signs, as well as a smartphone application (app) that allows patients to respond to different questions and tests that will monitor for new symptoms. This study may help researchers understand if wearing the device is a better tool than standard vital sign assessment tools done only while at the doctor's office or hospital, and if using the smartphone app is a better tool than standard assessment tools used while in the doctor's office or hospital.

Clinical Trial Description

PRIMARY OBJECTIVES: I. Develop patient-specific algorithms to predict the trajectory of cytokine release syndrome (CRS) and or neurotoxicity and time to escalation of medical intervention is needed. (Arm 1) II. Establish the validity for the use of mobile technology to assess neurologic symptoms remotely. (Arm 1) III. Compare the time to escalation of potential medical intervention between remote monitoring (RM) and standard care (SC) based on retrospective analysis of clinical trial data. (Arm 1) IV. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 1) V. Define the range of physiologic variables associated with receipt of radiation and chemotherapy. (Arm 2) VI. Correlate PROs and physician rated CTCAE to biologic parameters. (Arm 2) VII. Establish the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters by quantifying false alerts and downstream clinical actions. (Arm 2) OUTLINE: ARM 1: Patients undergoing CAR-T therapy use the Biofourmis wearable device(s) and smartphone app to answer a series of questions about health and neurologic symptoms a few times a day for 5 weeks. ARM 2: Patients undergoing radiation therapy (RT) for head and neck, lung, or gastrointestinal cancers use the Biofourmis wearable device(s) for 60 to 90 days after completion of RT. Patients also use the smartphone app to answer a series of questions about health and neurologic symptoms before start of RT, after completion of RT, 3 months after completion of RT, and 1 year after completion of RT. In addition, patients complete weekly questionnaires regarding side effects and tolerance of the device. ;

Study Design

Related Conditions & MeSH terms

Carcinoma
Digestive System Neoplasms
Gastrointestinal Neoplasms
Head and Neck Carcinoma
Hematopoietic and Lymphoid Cell Neoplasm
Lung Carcinoma
Malignant Digestive System Neoplasm
Malignant Solid Neoplasm
Neoplasms

Clinical Trial Details

NCT number	NCT05018208
Study type	Observational
Source	Mayo Clinic
Contact	Clinical Trials Referral Office
Phone	855-776-0015
Email	mayocliniccancerstudies@mayo.edu
Status	Recruiting
Phase
Start date	December 15, 2021
Completion date	March 15, 2025

View Details

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