Clinical trial NCT05018208: Remote Monitoring in Cancer Care: a Platform Study
Official title: Remote Monitoring in Cancer Care: a Platform Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Carcinoma
Hematopoietic and Lymphoid Cell Neoplasm
Lung Carcinoma
Malignant Digestive System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1)
timeFrame: Up to 5 weeks
measure: Assessment of neurotoxicity via digital capture of neurological assessment (Arm 1)
timeFrame: Up to 5 weeks
measure: BF-Mayo Neuro test (Arm 1)
timeFrame: Up to 5 weeks
measure: Sensitivity, specificity, positive predictive value and negative predictive value of novel digital neurotoxicity tests (BF-Neuro) (Arm 1)
timeFrame: Up to 5 weeks
measure: Range of physiologic variables associated with receipt of radiation and chemotherapy (Arm 2)
timeFrame: Up to 1 year
measure: Quantification of false alerts and downstream clinical actions (Arm 2)
timeFrame: Up to 1 year
Secondary outcomes:
measure: Biovital index (Arm 1)
timeFrame: Up to 5 weeks
measure: BF-Mayo Neuro Test (Arm 1)
timeFrame: Up to 5 weeks
measure: Point-in-time assessment of physiological signals from wearable devices (Arm 1)
timeFrame: Up to 5 weeks
measure: Point-in-time assessment of physiological signals from standard of care devices (Arm 1)
timeFrame: Up to 5 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Jonas Paludo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: