Head and Neck CarcinomaNCT05018208
Remote Monitoring in Cancer Care: A Platform Study
An observational study of Head and Neck Carcinoma and Hematopoietic and Lymphoid Cell Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Lung Carcinoma
- What is being tested?
- Computer-Assisted Intervention, Patient Monitoring and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2021to 17 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- ARM 1: Non-English speaking
- ARM 1: Planned initiation of lymphodepleting chemotherapy in the inpatient setting
- ARM 2: Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Lung Carcinoma, Malignant Digestive System Neoplasm, Malignant Solid Neoplasm
- Being tested
- Computer-Assisted Intervention, Patient Monitoring, Questionnaire Administration
- Medical subject headings
- Hematologic Neoplasms, Lung Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted InterventionOther
Use smartphone app
Patient MonitoringProcedure or surgery
Also called medical monitoring, monitor
Wear Biofourmis wearable device(s)
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Computer-Assisted Intervention; Procedure: Patient Monitoring; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 weeks
Range of physiologic variables associated with receipt of radiation and chemotherapy (Arm 2)
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start15 Dec 2021
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonas Paludo, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018208
- Sponsor's protocol ID
- MC211001
- Other IDs
- NCI-2021-07955, 21-002043
- Status last verified
- Oct 2025
- First submitted
- 3 Aug 2021
- Last updated
- 30 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Monitoring in Cancer Care: A Platform Study
- ClinicalTrials.gov ID
- NCT05018208
- Acronym / sponsor ID
- MC211001
- Conditions
- Head and Neck Carcinoma, Hematopoietic and Lymphoid Cell Neoplasm, Lung Carcinoma, Malignant Digestive System Neoplasm, Malignant Solid Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (wearable device[s], smartphone app) | – | Other: Computer-Assisted Intervention, Procedure: Patient MonitoringPatients 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 (wearable device[s], smartphone app, questionnaires) | – | Other: Computer-Assisted Intervention, Procedure: Patient Monitoring, Other: Questionnaire AdministrationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- ARM 1: Non-English speaking
- ARM 1: Planned initiation of lymphodepleting chemotherapy in the inpatient setting
- ARM 2: Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-Assisted InterventionUse smartphone app | Other | Arm 1 (wearable device[s], smartphone app), Arm 2 (wearable device[s], smartphone app, questionnaires) |
| Patient MonitoringAlso: medical monitoring, monitorWear Biofourmis wearable device(s) | Procedure or surgery | Arm 1 (wearable device[s], smartphone app), Arm 2 (wearable device[s], smartphone app, questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Arm 2 (wearable device[s], smartphone app, questionnaires) |
Primary outcome
Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1)
Time frame: Up to 5 weeks
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.
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.
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.
Range of physiologic variables associated with receipt of radiation and chemotherapy (Arm 2)
Time frame: Up to 1 year
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.
4 secondary outcomes
Biovital index (Arm 1)
Time frame: Up to 5 weeks
BF-Mayo Neuro Test (Arm 1)
Time frame: Up to 5 weeks
Point-in-time assessment of physiological signals from wearable devices (Arm 1)
Time frame: Up to 5 weeks
Point-in-time assessment of physiological signals from standard of care devices (Arm 1)
Time frame: Up to 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas Paludo, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Carcinoma and Hematopoietic and Lymphoid Cell Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, specificity, positive predictive value and negative predictive value of remote monitoring-based CRS detection/ prediction (Arm 1) (time frame: Up to 5 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2025.