An interventional study of Oncology Intelligent Management Software and Conventional Offline Follow-up Group in Digital Health and Artificial Intelligence (AI), sponsored by Tianjin Medical University Second Hospital. Recruiting at 2 sites in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Tianjin Medical University Second Hospital · Not applicable, Interventional, and Supportive care
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.
Tianjin Medical University Second Hospital is the lead sponsor of 60 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Oncology Intelligent Management Software
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.
Other: Conventional Offline Follow-up Group
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.
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.
Incidence of any-grade adverse events
Proportion of participants experiencing any antineoplastic-related adverse event, graded by NCI CTCAE 5.0.
Time frame: Within 24 months of enrollment.
Incidence of severe adverse events (CTCAE grade ≥3)
Proportion of participants experiencing grade ≥3 bone marrow suppression, gastrointestinal events, rash, liver injury, or other CTCAE grade ≥3 events.
Time frame: Within 24 months of enrollment
Emergency department visit rate due to anticancer treatment-related adverse events
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.
Time frame: 12 months after enrollment
30-day readmission rate related to anticancer treatment-related adverse events
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.
Time frame: 12 months after enrollment; each readmission assessed within 30 days after discharge
Incidence of anticancer drug dose reduction due to adverse events
Proportion of participants requiring at least one reduction in anticancer drug dose due to an adverse event, as documented in the medical record.
Time frame: 12 months after enrollment
Incidence of treatment delay due to adverse events
Proportion of participants with at least one anticancer treatment cycle delayed or temporarily interrupted due to an adverse event.
Time frame: 12 months after enrollment
Incidence of missed anticancer doses
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).
Time frame: 12 months after enrollment
Median time to adverse event recovery
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.
Time frame: From adverse event onset to recovery, assessed up to 12 months after enrollment
Monthly mean number of missed oral anticancer doses
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).
Time frame: Monthly for 12 months after enrollment
Protocol adherence rate among clinical trial participants (exploratory)
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.
Time frame: 12 months after enrollment
Protocol deviation incidence among clinical trial participants (exploratory)
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.
Time frame: 12 months after enrollment
Plan to share: No — 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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Tianjin Medical University Second Hospital