AI-assisted whole-course management for safe medicine use in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center study enrolls adults with advanced solid tumors who are starting or receiving systemic anticancer therapy. Participants choose either a digital management group using an app for medication reminders, AI-assisted lab results interpretation, adverse event reporting, and clinician alerts, or a conventional group with standard follow-up by outpatient visits and phone calls. Over 12 months, the study looks at overall and severe adverse events, emergency visits, 30-day readmissions, dose changes, treatment delays, and time to recovery from adverse events. The goal is to see if digital whole-course management improves medication safety and reduces the burden on healthcare systems. The trial is conducted at Tianjin Medical University Second Hospital in Tianjin, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Tianjin Medical Unversity Second Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Department of Oncology, Tianjin Medical University Second Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Principal investigator: Haitao Wang, Ph.D — Tianjin Medical University Second Hospital
• Study coordinator: Haitao Wang, Ph.D
• Email: peterrock2000@126.com
• Phone: +86-022-88321190

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.