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

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.

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