Remote Monitoring in Cancer Care: A Platform Study

NCT05018208 | Completed FDA Device

• 3 other identifiers: MC211001NCI-2021-0795521-002043
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Biovital index (Arm 1)

  Up to 5 weeks

• BF-Mayo Neuro Test (Arm 1)

  Up to 5 weeks

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

  Up to 5 weeks

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

  Up to 5 weeks

Study Arms (2)

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; Procedure: Patient 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: Computer-Assisted Intervention; Procedure: Patient Monitoring; Other: Questionnaire Administration

Interventions

Computer-Assisted Intervention OTHER

Use smartphone app

Arm 1 (wearable device[s], smartphone app); Arm 2 (wearable device[s], smartphone app, questionnaires)

Patient Monitoring PROCEDURE

Wear Biofourmis wearable device(s)

Also known as: medical monitoring, monitor

Arm 1 (wearable device[s], smartphone app); Arm 2 (wearable device[s], smartphone app, questionnaires)

Questionnaire Administration OTHER

Complete questionnaires

Arm 2 (wearable device[s], smartphone app, questionnaires)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hematologic Neoplasms; Lung Neoplasms; Gastrointestinal Neoplasms

Interventions

Remote Patient Monitoring

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Jonas Paludo, M.D.

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 24, 2021
• Study Start: December 15, 2021
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)