AI-Assisted Chemotherapy Side Effect Management

Condition(s) studied

Investigational drug(s) / intervention(s)

LLM-assisted chemotherapy side effect management: Healthcare providers collect patient symptoms during clinic visits, anonymize the information, and input it into the LLM system via temporary chat sessions. The LLM generates management recommendations which physicians review and consider when adjusting treatment plans. Healthcare providers anonymize patient information and input into LLM using temporary chat sessions. LLM recommendations serve as reference only, with physicians making all final clinical decisions.

Study summary

This two-stage adaptive randomized controlled trial evaluates the feasibility and preliminary efficacy of large language model (LLM)-assisted intervention for managing chemotherapy side effects in patients with solid tumors. Adults with histologically confirmed breast or colorectal cancer scheduled for at least 3 months of systemic chemotherapy will be randomly assigned (1:1) to receive either LLM-assisted care or standard care.

The study employs an adaptive design with initial enrollment of 60 patients (30 per arm), followed by interim analysis. Unless enrollment is stopped for safety reasons identified at interim analysis, an additional 114 patients will be enrolled for a maximum total of 174 patients (87 per arm).

In the intervention group, healthcare providers input anonymized patient symptom data into an LLM system using sessions where data is not retained, which generates evidence-based management recommendations. Physicians critically review these recommendations and use them as reference for clinical decision-making, with final treatment decisions remaining under physician discretion. The control group receives standard supportive care without LLM assistance.

The primary outcome is change in health-related quality of life measured by EORTC QLQ-C30 global health status/QoL scale from baseline to end of treatment. Secondary outcomes include proportion achieving clinically meaningful improvement (≥8-point increase), treatment adherence, dose intensity, healthcare resource utilization, and physician acceptance of LLM recommendations.

Eligibility

Primary outcome measure(s)

• Change in health-related quality of life measured by EORTC QLQ-C30 global health status/QoL scale (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 - Global Health Status/Quality of Life Scale) — Baseline, mid-treatment, end of treatment, 3 months post-treatment (up to 9 months)
  Change in health-related quality of life measured by EORTC QLQ-C30 global health status/QoL scale (range 0-100, higher scores indicate better outcomes; less decline indicates better outcomes)

Trial sites (1)

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