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OpenTrials
Completed

NCT Number: NCT05018208

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.

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Key information

Conditions

Head and Neck Carcinoma Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hematologic Neoplasms Hematopoietic and Lymphoid Cell Neoplasm Hemic and Lymphatic Diseases Lung Carcinoma Lung Diseases Lung Neoplasms Malignant Digestive System Neoplasm Malignant Solid Neoplasm Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-Assisted Intervention

Other

Use smartphone app

Patient Monitoring

Procedure

Wear Biofourmis wearable device(s)

Other names: medical monitoring, monitor

Questionnaire Administration

Other

Complete questionnaires

Primary outcomes

  1. Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1)

    Time frame: Up to 5 weeks

  2. Assessment of neurotoxicity via digital capture of neurological assessment (Arm 1)

    Time frame: 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.

  3. BF-Mayo Neuro test (Arm 1)

    Time frame: Up to 5 weeks

    Will assess agreement and concordance between BF-Mayo Neuro test and ICE-based assessment of neurotoxicity.

  4. Sensitivity, specificity, positive predictive value and negative predictive value of novel digital neurotoxicity tests (BF-Neuro) (Arm 1)

    Time frame: Up to 5 weeks

    Will compare to standard in-person ICE based neurotoxicity assessment.

  5. Range of physiologic variables associated with receipt of radiation and chemotherapy (Arm 2)

    Time frame: Up to 1 year

  6. Quantification of false alerts and downstream clinical actions (Arm 2)

    Time frame: 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 outcomes

  1. Biovital index (Arm 1)

    Time frame: 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.

  2. BF-Mayo Neuro Test (Arm 1)

    Time frame: 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.

  3. Point-in-time assessment of physiological signals from wearable devices (Arm 1)

    Time frame: 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.

  4. Point-in-time assessment of physiological signals from standard of care devices (Arm 1)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2021
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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