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

9 september 2026 uppdaterad av: 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.

Studieöversikt

Studietyp

Interventionell

Inskrivning (Beräknad)

470

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Minnesota
      • Rochester, Minnesota, Förenta staterna, 55905
        • Mayo Clinic in Rochester
        • Kontakt:
        • Huvudutredare:
          • Tufia C. Haddad, MD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: 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.
Experimentell: 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.
Participants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor
Andra namn:
  • TempShield
Patients complete questionnaires and study surveys
Andra namn:
  • Undersökningar
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
Andra namn:
  • SKYDDA
  • Smart Health Integration for Early Life-saving Detection

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Reach - screening eligibility
Tidsram: Baseline
Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation.
Baseline
Reach - enrollment rates
Tidsram: Baseline
Enrollment rates will be assessed by the percentage of screened patients who enroll in the study.
Baseline
Reach - representativeness of enrollment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Baseline
Assessed by staff-reported reasons for screening not being completed. Results will be analyzed and reported descriptively.
Baseline
Intervention fidelity
Tidsram: 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
Tidsram: 90 days
Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed.
90 days
Feasibility - symptoms recorded
Tidsram: 90 days
Assessed by the percent overall of complete symptom data transmitted
90 days

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Penetration - enrollment
Tidsram: Baseline
Assessed by the proportion of sites and individual work units who enroll patients
Baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Utredare

  • Huvudutredare: Tufia C. Haddad, MD, Mayo Clinic

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

15 november 2026

Primärt slutförande (Beräknad)

30 juni 2031

Avslutad studie (Beräknad)

30 juni 2031

Studieregistreringsdatum

Först inskickad

3 september 2026

Först inskickad som uppfyllde QC-kriterierna

3 september 2026

Första postat (Faktisk)

9 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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