LLM-Generated Plain-Language Patient Synopses to Improve Comprehension in Hematology and Oncology (oncOPAL)

NCT07519811 | Recruiting DMC

• 1 other identifier: oncOPAL-V1.0
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hematologic Neoplasms; Oncologic Disorders

Keywords

Patient-Provider Communication; Patient Health Literacy; Large Language Model

Outcome Measures

Primary Outcomes (1)

• Patient Comprehension Score

  Comprehension of the patient synopsis measured using a 5-item scale based on the Patient Education Materials Assessment Tool (PEMAT; scores range from 1 to 10, with higher scores indicating better comprehension), assessing overall comprehension and comprehension of diagnosis, treatment, next steps, and medical terminology. The score is calculated as the mean of all five items (range 0-10; higher scores indicate better comprehension).

  At the time of hospital discharge (Day 0), assessed immediately after reading the synopsis (approximately 15-30 minutes after receipt)

Secondary Outcomes (5)

• Patient Satisfaction with Information Received

  Day 0, assessed immediately after reading the synopsis

• Subjective Uncertainty Reduction

  Day 0, before and after reading the synopsis

• Patient Preference for Synopsis Format

  Day 0, assessed immediately after reading the synopsis

• Physician Review Time

  Day 0, recorded at time of physician review

• Physician Correction Rate

  Day 0, recorded at time of physician review

Study Arms (2)

Intervention: LLM-Simplified Synopsis

EXPERIMENTAL

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.

Other: LLM-Generated Plain-Language Patient Synopsis

Control: Standard Synopsis

NO INTERVENTION

Participants receive the standard discharge letter synopsis only, as provided in routine clinical care.

Interventions

LLM-Generated Plain-Language Patient Synopsis OTHER

A locally implemented large language model (GPT-OSS, on-premise) automatically rewrites selected sections of the hospital discharge letter (Current Status, Medical History, Epicrisis, and Further Management) into plain language. A study physician reviews the output for accuracy before it is provided to the patient. The system is not classified as a medical device and is not used for diagnosis or treatment decisions. No patient data are transmitted to external servers.

Intervention: LLM-Simplified Synopsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Technical University Munich

Munich, Bavaria, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Krischan Braitsch, MD

CONTACT

+49 089 4140 1268; krischan.braitsch@tum.de

Lisa C. Adams, MD

CONTACT

+49 089 4140 1084; lisa.adams@tum.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Blinding of participants and care providers is not possible, as the intervention group receives a visibly additional simplified synopsis. Questionnaire data are analyzed blinded to group assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2:1 block randomization (intervention : control) with permuted blocks of variable size (4-6). A separate exploratory translation component may be conducted for patients with insufficient German language proficiency, subject to operational feasibility. This component is non-randomized and descriptive only.

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 9, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)