SIMPLIFY-CT: A Prospective, Quasi-Randomised Comparative Study of Patient-Friendly Simplification of CT Staging Reports Using an On-Premise Large Language Model (LLM)

SIMPLIFY-CT: A Prospective, Quasi-Randomised Comparative Study of Patient-Friendly Simplification of CT Staging Reports Using an On-Premise Large Language Model (LLM) - SIMPLIFY-CT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00036710

Enrollment

200

Registered

2025-04-24

Start date

2025-04-21

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

All types of cancer

Interventions

Group 1: Simplified CT staging reports with an LLM (intervention group) Group 2: Original CT staging reports without modification (control group)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Adult patients (= 18 years) • Confirmed diagnosis of cancer • Scheduled CT restaging at TUM University Hospital • At least one prior CT staging at the same institution with an available radiology report • Written informed consent

Exclusion criteria

Exclusion criteria: • Refusal to participate or subsequent withdrawal of consent • Inability to comprehend study procedures or complete questionnaires (e.g., cognitive impairment, significant language barrier)

Design outcomes

Primary

Measure	Time frame
(i) Reading time (minutes) required to finish the report. (ii) Ten patient-reported ratings after reading (7-point Likert scales): mental demand, effort, frustration, clarity, readability, comprehension, helpfulness, overall informativeness, confidence in the report, global rating.	—

Secondary

Measure	Time frame
Feasibility of report simplification: • Number of factual errors, omissions, insertions and their clinical severity • Word-count reduction • Reduction of medical jargon • Improvement in readability indices (FRES, FKGL, SMOG, Gunning-Fog, Coleman-Liau) Additional patient and quality outcomes: • Change in anxiety/concerns (pre vs. post) • Clinical usefulness and relevance (Likert) • Overall report quality (poor – excellent)	—

Measure

Time frame

Feasibility of report simplification: • Number of factual errors, omissions, insertions and their clinical severity • Word-count reduction • Reduction of medical jargon • Improvement in readability indices (FRES, FKGL, SMOG, Gunning-Fog, Coleman-Liau) Additional patient and quality outcomes: • Change in anxiety/concerns (pre vs. post) • Clinical usefulness and relevance (Likert) • Overall report quality (poor – excellent)

—

Countries

Germany

Contacts

Public ContactFelix Busch

Institut für diagnostische und interventionelle Radiologie, TUM Klinikum rechts der Isar

felix.busch@tum.de+49 89 4140-1180

Outcome results

None listed

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