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AI-Assisted Chemotherapy Side Effect Management

A Randomized Controlled Trial of AI-Assisted Chemotherapy Side Effect Management in Solid Tumor Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010951
Enrollment
174
Registered
2025-08-28
Start date
2025-10-20
Completion date
Unknown
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Behavioral : LLM Intervention Group In the intervention group, LLM-assisted care is conducted as follows: 1.During outpatient visits, clinicians collect patient symptoms and relevant clinical informat
only non-specific information such as age, symptoms, and general clinical context are input into the LLM. To enhance privacy and data security, a temporary chat session (e.g., the “temporary” mode in
final clinical decisions and implementation are made solely by the physician, who retains full responsibility for patient care. 5.Based on the reviewed recommendations, clinicians may adjust the patie

Sponsors

The Catholic University of Korea, Incheon St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients (= 18 years old) diagnosed with histologically confirmed solid malignancies (breast cancer, colorectal cancer) Patients scheduled to receive at least 3 months of systemic chemotherapy ECOG performance status 0-2

Exclusion criteria

Exclusion criteria: Severe psychiatric disorders Cognitive impairment affecting ability to report symptoms Presence of cancer-related symptoms prior to chemotherapy initiation Concurrent participation in trials evaluating other symptom management interventions Inability to provide informed consent Life expectancy less than 6 months

Design outcomes

Secondary

MeasureTime frame
Proportion of patients with =8 points improvement in EORTC QLQ-C30 global health status/QoL scale;Frequency of grade 3-4 toxicities according to CTCAE v5.0

Primary

MeasureTime frame
Change in health-related quality of life measured by EORTC QLQ-C30 global health status/QoL scale

Countries

Korea, Republic of

Contacts

Public Contactbowon kim

The Catholic University of Korea, Incheon St. Mary's Hospital

107qhdnjs@naver.com+82-32-280-6523

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026