- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07810400
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
Status
Har inte rekryterat ännu
Intervention / Behandling
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
- Namn: Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-post: mayocliniccancerstudies@mayo.edu
Studieorter
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
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Kontakt:
- Clinical Trials Referral Office
- Telefonnummer: 855-776-0015
- E-post: mayocliniccancerstudies@mayo.edu
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Huvudutredare:
- Tufia C. Haddad, MD
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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 |
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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.
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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.
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Participants will wear the TempShield device by AION an FDA-approved, medical grade continuous temperature monitoring (CTM) wearable sensor
Andra namn:
Patients complete questionnaires and study surveys
Andra namn:
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:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Reach - screening eligibility
Tidsram: Baseline
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Screening eligibility rates will be assessed by the percentage of eligible patients screened for study participation.
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Baseline
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Reach - enrollment rates
Tidsram: Baseline
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Enrollment rates will be assessed by the percentage of screened patients who enroll in the study.
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Baseline
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Reach - representativeness of enrollment
Tidsram: Baseline
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Representativeness of enrollment will be assessed by comparison of urban-rural residence / Rural-Urban Commuting Area (RUCA) codes recorded for participants
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Baseline
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Acceptability - PRISM PCSI Staff Survey
Tidsram: Baseline
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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.
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Baseline
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Usability - Remote Patient Monitoring (RPM) Patient/Caregiver Survey
Tidsram: 90 days
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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.
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90 days
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Enrollment fidelity
Tidsram: Baseline
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Assessed by staff-reported reasons for screening not being completed.
Results will be analyzed and reported descriptively.
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Baseline
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Intervention fidelity
Tidsram: 90 days
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Assessed by documentation of intervention delivery - delivered as intended or reasons recorded for adaptation of intervention.
Results will be analyzed and reported descriptively.
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90 days
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Feasibility - treatment adherence
Tidsram: 90 days
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Assessed by the percent overall of electronic patient-reported outcome (ePRO) assessments completed.
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90 days
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Feasibility - symptoms recorded
Tidsram: 90 days
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Assessed by the percent overall of complete symptom data transmitted
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90 days
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Penetration - enrollment
Tidsram: Baseline
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Assessed by the proportion of sites and individual work units who enroll patients
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Baseline
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
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
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Neoplasmer efter histologisk typ
- Lymfatiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Hemiska och lymfsjukdomar
- Neoplasmer
- Lymfom
- Sjukvårdskvalitet, tillgång och utvärdering
- Undersökningstekniker
- Epidemiologiska metoder
- Datainsamling
- Hälsovårdsutvärderingsmekanismer
- Hälsovårdskvalitet
- Folkhälsa
- Miljö och folkhälsa
- Undersökningar och frågeformulär
Andra studie-ID-nummer
- 26-008945
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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