A Study Of Remote Patient Monitoring (RPM) Program For Cancer Patients Initiating Cancer-directed Therapy

September 9, 2026 updated by: Mayo Clinic

Development And Pilot Implementation Of A Novel Remote Patient Monitoring Program For Cancer Patients Initiating Cancer-directed Therapy: The SHIELD (Smart Health Integration For Early Life-saving Detection)

This clinical trial develops and studies whether using a new remote patient monitoring (RPM) program [Smart Health Integration for Early Life-saving Detection (SHIELD)] in cancer practices helps manage infectious complications among cancer patients who are initiating systemic therapy. Infectious complications are among the most common, costly, and clinically consequential side effects experienced by patients receiving cancer-directed therapy and can lead to increased emergency department evaluations, reduced quality of life, and death. National guidelines support using management strategies within cancer practices for selected patients with infectious complications; however, implementation remains limited by the need for reliable monitoring programs while the patient is at home. The SHIELD program combines remote electronic patient-reported outcome symptom assessments with continuous temperature monitoring (CTM). Patients complete electronic patient-reported outcome symptom assessments on a mobile application and wear a CTM device. Patient responses and CTM data are integrated into the electronic health record, which can create alerts. Cancer practice clinical assistants and nurses review the alerts and create care escalation pathways to the clinical care team or emergency department if needed. The application can also deliver patient education and guidance for self-management of low-grade symptoms. Using the SHIELD program in cancer practices may be an effective way to help manage infectious complications among cancer patients who are initiating systemic therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
470

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
        • Contact:
        • Principal Investigator:
          • Tufia C. Haddad, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patient Inclusion Criteria, Aim 1:

  • Documented history of cancer
  • Actively receiving cancer care at any Mayo Clinic Midwest practice site
  • Involved in or impacted by the care or participation of eligible patients

Patient Inclusion Criteria, Aim 2

  • Documented diagnosis of cancer
  • ≥ 1 year of age as the CTM device only supports these ages
  • Initiating systemic cancer-directed treatment at a Mayo Clinic Midwest site
  • Able to read and speak English or Spanish (or have a caregiver capable of either) as the current technologies only support those languages

Caregiver Inclusion Criteria

  • Age 18 years or older.
  • Identified as the eligible minor pediatric patient's parent or legal guardian

Healthcare Professional Inclusion Criteria

  • A hematology/oncology clinical, research, RPM, operational, administrative, managerial, or technical/electronic health record (EHR) or other healthcare professional supporting or supervising, or directly affected by the SHIELD program development and pilot implementation study at a participating Mayo Clinic Health System site or Mayo Clinic in Rochester work unit.

Exclusion Criteria:

Patient Exclusion Criteria:

  • History of hematopoietic cell transplant or adoptive cellular or bispecific antibody therapy [i.e., chimeric antigen receptor (CAR) T-cell (CAR-T)] within the prior 100 days
  • Enrolled in hospice or expected life span < 6 months

Caregiver and Healthcare Professional Exclusion Criteria

  • Unable or unwilling to provide consent to participate in study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Interview and group discussion (Aim 1)
Prior to program/intervention implementation, interviews and group discussions will be held with patients, caregivers, and hematology/oncology professional staff to determine who will benefit from SHIELD, whether the intended population can be reached, and whether SHIELD is perceived as appropriate for the patient population.
Experimental: Aim 2 (SHIELD program)
Patients participate in the refined SHIELD program over 90 days and complete ePRO symptom assessments and wear a medical grade CTM device. Patients may also receive care escalation to clinical care team or emergency services as needed as well as patient education and guidance for self-management of low-grade symptoms on study.
Other: AION TempShield
Participants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor
Other Names:
  • TempShield
Other: Questionnaires
Patients complete questionnaires and study surveys
Other Names:
  • Surveys
Behavioral: Smart Phone Application-based Intervention - SHIELD
Smart Health Integration for Early Life-saving Detection (SHIELD) program used as an electronic patient-reported outcomes (ePRO) and continuous temperature monitoring (CTM)-integrated remote patient monitoring (RPM) care delivery model
Other Names:
  • SHIELD
  • Smart Health Integration for Early Life-saving Detection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reach - screening eligibility
Time Frame: Baseline
Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation.
Baseline
Reach - enrollment rates
Time Frame: Baseline
Enrollment rates will be assessed by the percentage of screened patients who enroll in the study.
Baseline
Reach - representativeness of enrollment
Time Frame: Baseline
Representativeness of enrollment will be assessed by comparison of urban-rural residence / Rural-Urban Commuting Area (RUCA) codes recorded for participants
Baseline
Acceptability - PRISM PCSI Staff Survey
Time Frame: Baseline
The Practical Robust Implementation and Sustainability (PRISM) Contextual Survey Instrument (PCSI) staff survey consists of one question ascertaining the staff role and 29 questions related to perspectives, sustainability, and organizational characteristics of implementing the SHIELD remote patient monitoring program. Questions are answered on a 5-point scale (completely disagree, disagree, neither agree nor disagree, agree, completely agree). Results will be analyzed and reported descriptively.
Baseline
Usability - Remote Patient Monitoring (RPM) Patient/Caregiver Survey
Time Frame: 90 days
The Remote Patient Monitoring (RPM) survey consists of 17 questions answered on a 5-point scale (strongly disagree, disagree, neither agree nor disagree, agree, strongly agree) and two open-ended questions related to what impressed and what disappointed about the RPM program. Results will be analyzed and reported descriptively.
90 days
Enrollment fidelity
Time Frame: Baseline
Assessed by staff-reported reasons for screening not being completed. Results will be analyzed and reported descriptively.
Baseline
Intervention fidelity
Time Frame: 90 days
Assessed by documentation of intervention delivery - delivered as intended or reasons recorded for adaptation of intervention. Results will be analyzed and reported descriptively.
90 days
Feasibility - treatment adherence
Time Frame: 90 days
Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed.
90 days
Feasibility - symptoms recorded
Time Frame: 90 days
Assessed by the percent overall of complete symptom data transmitted
90 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Penetration - enrollment
Time Frame: Baseline
Assessed by the proportion of sites and individual work units who enroll patients
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Tufia C. Haddad, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 26-008945

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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