Remote Monitoring in Cancer Care: A Platform Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Remote Monitoring in Cancer Care: A Platform Study

Conditions
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Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Lung Carcinoma, Malignant Digestive System Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Computer-Assisted Intervention
* Procedure: Patient Monitoring
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1 (wearable device[s], smartphone app)<br>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<br>* Use smartphone app<br>Procedure: Patient Monitoring<br>* Wear Biofourmis wearable device(s)<br>* Other names: monitor;|
| Arm 2 (wearable device[s], smartphone app, questionnaires)<br>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: Computer-Assisted Intervention<br>* Use smartphone app<br>Procedure: Patient Monitoring<br>* Wear Biofourmis wearable device(s)<br>* Other names: monitor;Other: Questionnaire Administration<br>* Complete questionnaires<br>|

What is the study measuring?
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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 | 
| Patient-reported outcomes (PROs) and physician rated Common Terminology Criteria for Adverse Events (CTCAE) (Arm 2) | Will correlate with biologic parameters. | 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 |