Clinical trial · Interventional
LLM-Generated Plain-Language Patient Synopses to Improve Comprehension in Hematology and Oncology (oncOPAL)
Prospective Randomized Controlled Trial to Evaluate Locally Implemented Large Language Models (LLMs) for Simplifying Patient Communication in Hematology and Oncology
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study tests whether patients with blood cancer or other cancers better understand their medical information when it is rewritten in plain language by an artificial intelligence (AI) system. When patients are discharged from the hospital, they receive a medical letter summarizing their diagnosis, treatment, and next steps. These letters are often written in technical language that is difficult for patients to understand. In this study, an AI language model running on the hospital's own secure servers rewrites parts of this letter into simpler language. A physician checks the simplified version before the patient receives it. Patients are randomly assigned to one of two groups. One group receives both the standard medical letter and the AI-simplified version. The other group receives the standard letter only. A separate group of patients who do not speak German well will receive a simplified and translated version. After reading their letter, all participants fill out a short questionnaire about how well they understood the information. The study takes place at TUM University Hospital (Klinikum rechts der Isar) in Munich, Germany.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Oncologic Disorders | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LLM-Generated Plain-Language Patient Synopsis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention: LLM-Simplified Synopsis
- description
- Participants receive the standard discharge letter synopsis plus an LLM-generated plain-language version of the following sections: Current Status, Medical History, Epicrisis, and Further Management. The simplified version is reviewed and approved by a study physician before being given to the patient.
- interventionNames
- Other: LLM-Generated Plain-Language Patient Synopsis
- type
- NO_INTERVENTION
- label
- Control: Standard Synopsis
- description
- Participants receive the standard discharge letter synopsis only, as provided in routine clinical care.
Primary outcomes (1)
- measure
- Patient Comprehension Score
- timeFrame
- At the time of hospital discharge (Day 0), assessed immediately after reading the synopsis (approximately 15-30 minutes after receipt)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older * Inpatient of the Department of Medicine III (Hematology/Oncology) at TUM University Hospital (Klinikum rechts der Isar), Munich, Germany * Receipt of a discharge letter including the sections Current Status, Medical History, Epicrisis, and Further Management as part of routine clinical care * Capacity to provide informed consent * Written informed consent following the consent procedure Exclusion Criteria: * Cognitive impairment precluding independent assessment of comprehension (e.g., dementia, severe encephalopathy) * Participation in another study with potential influence on the study endpoints * Lack of capacity to provide informed consent * Refusal to participate in the study
References
Publications (0)
Data not yet available