Remote Monitoring in Cancer Care: A Platform Study

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm; Head and Neck Carcinoma; Lung Carcinoma; Malignant Digestive System Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Other: Computer-Assisted Intervention; Procedure: Patient Monitoring

Detailed 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing standard of care CAR-T cell therapy in the outpatient setting at Mayo Clinic. Patients undergoing standard of care radiation for (1) head and neck, (2) lung, or (3) gastrointestinal malignancies.

Description

Inclusion Criteria:

• ARM 1: Age >= 18 years
• ARM 1: Provide written informed consent
• ARM 1: Patients undergoing commercial CAR-T cell therapy in an outpatient setting
• ARM 2: Age >= 18 years
• ARM 2: Provide written informed consent
• ARM 2: Patients with a plan to undergo radiation therapy for lung, gastrointestinal, or head and neck cancer

Exclusion Criteria:

• ARM 1: Non-English speaking
• ARM 1: Planned initiation of lymphodepleting chemotherapy in the inpatient setting
• ARM 2: Non-English speaking

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm 1 (wearable device[s], smartphone app); 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.	Other: Computer-Assisted Intervention; Use smartphone app; Procedure: Patient Monitoring; Wear Biofourmis wearable device(s); Other Names: monitor; medical monitoring
Arm 2 (wearable device[s], smartphone app, questionnaires); Patients undergoing radiation therapy (RT) for head and neck, lung, or gastrointestinal cancers use the Biofourmis wearable device(s) for 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.	Other: Questionnaire Administration; Complete questionnaires; Other: Computer-Assisted Intervention; Use smartphone app; Procedure: Patient Monitoring; Wear Biofourmis wearable device(s); Other Names: monitor; medical monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1)		Up to 5 weeks
Assessment of neurotoxicity via digital capture of neurological assessment (Arm 1)	Will assess agreement and concordance between assessment of neurotoxicity via digital capture of neurological assessment (ICE) as compared to standard in-person assessment.	Up to 5 weeks
BF-Mayo Neuro test (Arm 1)	Will assess agreement and concordance between BF-Mayo Neuro test and ICE-based assessment of neurotoxicity.	Up to 5 weeks
Sensitivity, specificity, positive predictive value and negative predictive value of novel digital neurotoxicity tests (BF-Neuro) (Arm 1)	Will compare to standard in-person ICE based neurotoxicity assessment.	Up to 5 weeks
Range of physiologic variables associated with receipt of radiation and chemotherapy (Arm 2)		Up to 1 year
Quantification of false alerts and downstream clinical actions (Arm 2)	Will be used for the establishment of the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biovital index (Arm 1)	Will assess correlation between Biovital index and BF-Mayo Neuro Test and adverse clinical events. Both continuous variables (physiologic parameters) and categorical variables (events) will be used to generate a mixed effects logistic regression model with repeated measures. The goal is to identify patterns of changes in the continuous data associated with either clinically relevant or significant events.	Up to 5 weeks
BF-Mayo Neuro Test (Arm 1)	Will assess correlation between Biovital index and BF-Mayo Neuro Test and adverse clinical events. Both continuous variables (physiologic parameters) and categorical variables (events) will be used to generate a mixed effects logistic regression model with repeated measures. The goal is to identify patterns of changes in the continuous data associated with either clinically relevant or significant events.	Up to 5 weeks
Point-in-time assessment of physiological signals from wearable devices (Arm 1)	Will assess agreement and concordance from wearable vs. standard of care devices. Intraclass correlation coefficients (ICC) and Bland-Altman methods will be used for agreement and concordance analysis of the remote monitor reading compared to the "gold standard" standard of care devices.	Up to 5 weeks
Point-in-time assessment of physiological signals from standard of care devices (Arm 1)	Will assess agreement and concordance from wearable vs. standard of care devices. ICC and Bland-Altman methods will be used for agreement and concordance analysis of the remote monitor reading compared to the "gold standard" standard of care devices.	Up to 5 weeks

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jonas Paludo, M.D., Mayo Clinic in Rochester

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): April 17, 2025
• Study Completion (Actual): April 17, 2025

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 17, 2021
• First Posted (Actual): August 24, 2021

Study Record Updates

• Last Update Posted (Estimated): October 30, 2025
• Last Update Submitted That Met QC Criteria: October 28, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Lung Diseases; Hematologic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Hemic and Lymphatic Diseases; Lung Neoplasms; Hematologic Neoplasms; Gastrointestinal Neoplasms; Health Services Administration; Delivery of Health Care; Telemedicine; Patient Care Management; Remote Patient Monitoring
• Other Study ID Numbers: MC211001 (Mayo Clinic in Rochester); NCI-2021-07955 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 21-002043 (Other Identifier: Mayo Clinic Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No