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NCT Number: NCT07810400

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

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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Key information

Conditions

Cancer Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Tufia C. Haddad, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smartphone Application-based Intervention - SHIELD

Behavioral

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

AION TempShield

Other

Participants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor

Other names: TempShield

questionnaires

Other

Patients complete questionnaires and study surveys

Other names: Surveys

Primary outcomes

  1. Reach - screening eligibility

    Time frame: Baseline

    Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation.

  2. Reach - enrollment rates

    Time frame: Baseline

    Enrollment rates will be assessed by the percentage of screened patients who enroll in the study.

  3. 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

  4. 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.

  5. 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.

  6. Enrollment fidelity

    Time frame: Baseline

    Assessed by staff-reported reasons for screening not being completed. Results will be analyzed and reported descriptively.

  7. 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.

  8. Feasibility - treatment adherence

    Time frame: 90 days

    Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed.

  9. Feasibility - symptoms recorded

    Time frame: 90 days

    Assessed by the percent overall of complete symptom data transmitted

Secondary outcomes

  1. Penetration - enrollment

    Time frame: Baseline

    Assessed by the proportion of sites and individual work units who enroll patients

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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