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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)

NCT ID NCT07810400

NEW Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 470 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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., 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

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Conditions

The condition(s) this trial relates to.

cancer lymphoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cancer Lymphoma

How to take part

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  1. The study's own enquiry address

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  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

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    Open the record ↗

  4. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

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