Cancer, Lymphoma
Conditions
Brief 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.
Interventions
BEHAVIORALSmart 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
OTHERAION TempShield
Participants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor
OTHERQuestionnaires
Patients complete questionnaires and study surveys
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reach - screening eligibility | Baseline | Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation. |
| Reach - enrollment rates | Baseline | Enrollment rates will be assessed by the percentage of screened patients who enroll in the study. |
| Reach - representativeness of enrollment | Baseline | Representativeness of enrollment will be assessed by comparison of urban-rural residence / Rural-Urban Commuting Area (RUCA) codes recorded for participants |
| Acceptability - PRISM PCSI Staff Survey | 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. |
| Usability - Remote Patient Monitoring (RPM) Patient/Caregiver Survey | 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. |
| Enrollment fidelity | Baseline | Assessed by staff-reported reasons for screening not being completed. Results will be analyzed and reported descriptively. |
| Intervention fidelity | 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. |
| Feasibility - treatment adherence | 90 days | Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed. |
| Feasibility - symptoms recorded | 90 days | Assessed by the percent overall of complete symptom data transmitted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penetration - enrollment | Baseline | Assessed by the proportion of sites and individual work units who enroll patients |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORTufia C. Haddad, MD
Mayo Clinic
Outcome results
None listed