NCT07917351 AI-Assisted Whole-Course Management for Medication Safety and Healthcare Burden in Advanced Solid Tumors: A Prospective Controlled Study
| NCT ID | NCT07917351 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tianjin Medical University Second Hospital |
| Condition | Digital Health |
| Study Type | INTERVENTIONAL |
| Enrollment | 420 participants |
| Start Date | 2026-10-01 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 420 participants in total. It began in 2026-10-01 with a primary completion date of 2027-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Haitao Wang, Ph.D
PRINCIPAL INVESTIGATOR
Tianjin Medical University Second Hospital
Frequently Asked Questions
Who can join the NCT07917351 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Digital Health. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07917351 currently recruiting?
Yes, NCT07917351 is actively recruiting participants. Contact the research team at peterrock2000@126.com for enrollment information.
Where is the NCT07917351 trial being conducted?
This trial is being conducted at Tianjin, China, Tianjin, China.
Who is sponsoring the NCT07917351 clinical trial?
NCT07917351 is sponsored by Tianjin Medical University Second Hospital. The principal investigator is Haitao Wang, Ph.D at Tianjin Medical University Second Hospital. The trial plans to enroll 420 participants.