Remote Monitoring in Cancer Care: a Platform Study

Active, not recruiting

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

• Registration Number: NCT05018208
• Lead Sponsor: Mayo Clinic

Brief 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.

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 Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-17
• Study First Posted: 2021-08-24
• Study Start: 2021-12-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-09-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1 (wearable device[s], smartphone app)	Computer-Assisted Intervention	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 (wearable device[s], smartphone app, questionnaires)	Questionnaire Administration	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.
Arm 2 (wearable device[s], smartphone app, questionnaires)	Computer-Assisted Intervention	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.
Arm 1 (wearable device[s], smartphone app)	Patient Monitoring	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 (wearable device[s], smartphone app, questionnaires)	Patient Monitoring	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.

Primary Outcome Measures

Name	Time	Method
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)	Up to 5 weeks	Will assess agreement and concordance between assessment of neurotoxicity via digital capture of neurological assessment (ICE) as compared to standard in-person assessment.
BF-Mayo Neuro test (Arm 1)	Up to 5 weeks	Will assess agreement and concordance between BF-Mayo Neuro test and ICE-based assessment of neurotoxicity.
Sensitivity, specificity, positive predictive value and negative predictive value of novel digital neurotoxicity tests (BF-Neuro) (Arm 1)	Up to 5 weeks	Will compare to standard in-person ICE based neurotoxicity assessment.
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)	Up to 1 year	Will be used for the establishment of the feasibility for the use of wearable device for continuous, remote monitoring of physiologic parameters.

Secondary Outcome Measures

Name	Time	Method
Biovital index (Arm 1)	Up to 5 weeks	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.
Point-in-time assessment of physiological signals from standard of care devices (Arm 1)	Up to 5 weeks	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.
BF-Mayo Neuro Test (Arm 1)	Up to 5 weeks	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.
Point-in-time assessment of physiological signals from wearable devices (Arm 1)	Up to 5 weeks	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States