Remote Monitoring in Cancer Care: A Platform Study

Mayo Clinic

Status: Active, not recruiting

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

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05018208

MC211001 (Other Identifier)

NCI-2021-07955 (Registry Identifier)

21-002043 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

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

Description:

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.

Treatment:

Other: Computer-Assisted Intervention

Procedure: Patient Monitoring

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

Description:

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.

Treatment:

Other: Computer-Assisted Intervention

Procedure: Patient Monitoring

Other: Questionnaire Administration