Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

AI-Assisted Whole-Course Management for Medication Safety and Healthcare Burden in Advanced Solid Tumors: A Prospective Controlled Study

3 november 2026 bijgewerkt door: Tianjin Medical University Second Hospital

AI Agent-Enabled Whole-Course Management to Improve Anticancer Medication Safety and Reduce Healthcare Burden in Advanced Solid Tumors: A Prospective, Single-Center, Non-Randomized, Parallel-Group Real-World Controlled Study

This is a prospective, single-center, controlled real-world study in patients with advanced solid tumors (stage III-IV) receiving chemotherapy, targeted therapy, immunotherapy, or endocrine therapy. Participants who choose the digital management group use a smartphone-based oncology management application with medication reminders, AI-assisted laboratory report interpretation, adverse event self-reporting, and clinician alerts for critical values. Participants who choose the conventional group receive routine outpatient follow-up and telephone contact without digital tools. The study follows participants for 12 months to compare the incidence of overall and severe (CTCAE grade ≥3) adverse events, emergency department visits, 30-day readmission, dose reduction, treatment delay/missed doses, and time to adverse event recovery. The aim is to evaluate whether a digital whole-course management model improves medication safety, reduces healthcare burden, and supports treatment adherence in advanced cancer care.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

420

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300211
        • Werving
        • Tianjin Medical Unversity Second Hospital
        • Onderonderzoeker:
          • Dingkun Hou, Ph.D
        • Onderonderzoeker:
          • Jinhuan Wang, Ph.D
        • Onderonderzoeker:
          • Lili Wang, Ph.D
        • Contact:
        • Onderonderzoeker:
          • Hongzheng Li, M.M.
        • Contact:
        • Hoofdonderzoeker:
          • Haitao Wang, Ph.D
      • Tianjin, Tianjin Municipality, China
        • Werving
        • Department of Oncology, Tianjin Medical University Second Hospital
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  1. Histologically or cytologically confirmed malignant tumor, scheduled to receive or currently receiving systemic anticancer therapy (chemotherapy, targeted therapy, immunotherapy, or endocrine therapy).
  2. Age ≥18 years.
  3. For the digital management group: able to independently use a smartphone to scan a QR code to log in, photograph and upload laboratory reports, and complete online forms; for the control group: able to communicate by telephone and attend outpatient visits.
  4. Expected survival ≥12 months.
  5. Able to understand the study and provide written informed consent.
  6. Receiving regular home oral or cyclic intravenous anticancer treatment and requiring long-term out-of-hospital follow-up.
  7. Able to complete 12 months of follow-up.

Exclusion Criteria:

  1. Pregnant or breastfeeding women.
  2. Severe cognitive impairment or severe psychiatric illness precluding independent follow-up or causing extremely poor adherence.
  3. End-stage multi-organ failure or moribund condition with expected survival <12 months.
  4. Receiving only palliative supportive care, with no planned standard anticancer drug treatment.
  5. Other conditions judged by the investigator as unsuitable for this study.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Digital Management Group

Participants use a smartphone-based oncology management app for the entire 12-month follow-up: medication check-in with missed-dose reminders; photo upload and AI-assisted interpretation of laboratory reports with critical-value alerts to clinicians; CTCAE 5.0-based adverse event self-reporting with severity-triggered clinician notification; monthly online follow-up questionnaires; and a dedicated module for clinical trial participants.
Ander: Oncology Intelligent Management Software

A self-developed application integrating medication adherence reminders, AI-assisted laboratory interpretation, adverse event self-reporting, critical-value clinician alerts, monthly electronic follow-up, and clinical trial participant tracking.
Actieve vergelijker: Conventional Follow-up Group

Participants receive routine outpatient follow-up and intermittent telephone contact per standard departmental practice. No digital reminders, no AI-assisted laboratory interpretation, no home-based adverse event self-reporting, and no real-time critical-value alerts.
Ander: Conventional Offline Follow-up Group

The conventional management group reflects routine departmental practice: outpatient appointment-based follow-up, unstructured telephone follow-up, offline review of outside laboratory reports, passive reporting of adverse events at clinic visits or emergency department presentations, and no digital medication adherence reminders or real-time clinician alerts.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of any-grade adverse events
Tijdsspanne: Within 24 months of enrollment.

Proportion of participants experiencing any antineoplastic-related adverse event, graded by NCI CTCAE 5.0.
Within 24 months of enrollment.
Incidence of severe adverse events (CTCAE grade ≥3)
Tijdsspanne: Within 24 months of enrollment

Proportion of participants experiencing grade ≥3 bone marrow suppression, gastrointestinal events, rash, liver injury, or other CTCAE grade ≥3 events.
Within 24 months of enrollment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Emergency department visit rate due to anticancer treatment-related adverse events
Tijdsspanne: 12 months after enrollment

Proportion of participants with at least one emergency department visit due to an anticancer treatment-related adverse event during follow-up. Data source: medical records and participant-reported events confirmed by the study site.
12 months after enrollment
30-day readmission rate related to anticancer treatment-related adverse events
Tijdsspanne: 12 months after enrollment; each readmission assessed within 30 days after discharge

Among participants with at least one hospitalization related to an anticancer treatment-related adverse event, proportion readmitted within 30 days after discharge. Each discharge is followed for 30 days.
12 months after enrollment; each readmission assessed within 30 days after discharge
Incidence of anticancer drug dose reduction due to adverse events
Tijdsspanne: 12 months after enrollment

Proportion of participants requiring at least one reduction in anticancer drug dose due to an adverse event, as documented in the medical record.
12 months after enrollment
Incidence of treatment delay due to adverse events
Tijdsspanne: 12 months after enrollment

Proportion of participants with at least one anticancer treatment cycle delayed or temporarily interrupted due to an adverse event.
12 months after enrollment
Incidence of missed anticancer doses
Tijdsspanne: 12 months after enrollment

Among participants receiving oral anticancer therapy, proportion with at least one missed dose during follow-up, based on app check-in records (intervention group) or self-report/outpatient records (control group).
12 months after enrollment
Median time to adverse event recovery
Tijdsspanne: From adverse event onset to recovery, assessed up to 12 months after enrollment

Median time from onset of an eligible adverse event to recovery of symptoms and/or laboratory abnormality to baseline or CTCAE grade ≤1, estimated using Kaplan-Meier methods. Adverse events are graded by NCI CTCAE 5.0.
From adverse event onset to recovery, assessed up to 12 months after enrollment
Monthly mean number of missed oral anticancer doses
Tijdsspanne: Monthly for 12 months after enrollment

Mean number of missed oral anticancer doses per participant per month, calculated from app check-in records (intervention group) or self-report/outpatient records (control group).
Monthly for 12 months after enrollment
Protocol adherence rate among clinical trial participants (exploratory)
Tijdsspanne: 12 months after enrollment

Among participants concurrently enrolled in a clinical trial, proportion who complete protocol-specified treatment cycles and scheduled assessments without major protocol deviation, as documented by the site.
12 months after enrollment
Protocol deviation incidence among clinical trial participants (exploratory)
Tijdsspanne: 12 months after enrollment

Among participants concurrently enrolled in a clinical trial, proportion with at least one protocol deviation, classified by type and relationship to the digital management intervention.
12 months after enrollment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Tianjin Medical University Second Hospital

Onderzoekers

  • Hoofdonderzoeker: Haitao Wang, Ph.D, Tianjin Medical University Second Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 oktober 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

31 augustus 2028

Studieregistratiedata

Eerst ingediend

29 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 november 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • AIM-SAFE

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

The study protocol does not include a pre-specified plan or dedicated funding for sharing individual participant data with external researchers. Data will be maintained by the sponsor and participating sites in accordance with the approved informed consent and local regulatory requirements. This statement may be updated if a data sharing plan is established at a later stage.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren