Clinical trial · Interventional
Effectiveness of Original vs. AI-Generated Plain Language Summaries of Systematic Reviews
Patients' Perceptions and Comprehension of Original Versus AI-Generated Plain Language Summaries of Cochrane Oncology Systematic Reviews
- 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)
The study explores how patients with non-metastatic breast cancer perceive and comprehend original Plain Language Summary and AI-generated Plain Language Summary (PLS) of two systematic reviews from the Cochrane Library. The systematic reviews address exercise during adjuvant therapy and psychological interventions for non-metastatic breast cancer. The study, which is randomized and double-blind, aims to assess whether AI-generated PLS and original PLS differ in their influence on patients' intention to undertake and apply the recommendation presented in the summary, as well as their overall understanding of the study results.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AI-generated PLS | Behavioral | — | UNRESOLVED |
| Original PLS | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patients Receiving AI-generated Plain Language Summaries
- description
- Experimental Group: participants in this group receive two AI-generated Plain Language Summaries based on the scientific abstract of two Cochrane systematic reviews: Exercise during Adjuvant Therapy (1) and Psychological Interventions for Non-metastatic Breast Cancer (2).
- interventionNames
- Behavioral: AI-generated PLS
- type
- ACTIVE_COMPARATOR
- label
- Patients Receiving Original Plain Language Summaries
- description
- Active Comparative Group: participants in this group receive two original Plain Language Summaries based on the scientific abstract of two Cochrane systematic reviews: Exercise during Adjuvant Therapy (1) and Psychological Interventions for Non-metastatic Breast Cancer (2).
- interventionNames
- Behavioral: Original PLS
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * female patients with histologically confirmed non-metastatic breast cancer currently undergoing chemotherapy or radiotherapy: 1. neoadjuvant chemotherapy (with or without immunotherapy or antiHER2 therapy), 2. adjuvant chemotherapy (with or without immunotherapy or antiHER2 therapy), 3. adjuvant radiotherapy (including local and locoregional radiation treatment with possible radiotherapy boost where indicated). * patients need to be able to read and understand Croatian. Exclusion Criteria: * female patients with metastatic breast cancer. * female patients receiving only hormonal treatment.
References
Publications (18)
- BACKGROUNDHasannejadasl H, Roumen C, Smit Y, Dekker A, Fijten R. Health Literacy and eHealth: Challenges and Strategies. JCO Clin Cancer Inform. 2022 Sep;6:e2200005. doi: 10.1200/CCI.22.00005. PMID 36194843
- BACKGROUNDSeiler A, Jenewein J. Resilience in Cancer Patients. Front Psychiatry. 2019 Apr 5;10:208. doi: 10.3389/fpsyt.2019.00208. eCollection 2019. PMID 31024362
- BACKGROUNDGoerling U, Faller H, Hornemann B, Honig K, Bergelt C, Maatouk I, Stein B, Teufel M, Erim Y, Geiser F, Niecke A, Senf B, Wickert M, Buttner-Teleaga A, Weis J. Information needs in cancer patients across the disease trajectory. A prospective study. Patient Educ Couns. 2020 Jan;103(1):120-126. doi: 10.1016/j.pec.2019.08.011. Epub 2019 Aug 12. PMID 31474389
- BACKGROUNDDiefenbach M, Turner G, Carpenter KM, Sheldon LK, Mustian KM, Gerend MA, Rini C, von Wagner C, Gritz ER, McQueen A, Prayor-Patterson HM, Miller SM. Cancer and patient-physician communication. J Health Commun. 2009;14 Suppl 1(Suppl 1):57-65. doi: 10.1080/10810730902814079. PMID 19449269
- BACKGROUNDRosa WE, Levoy K, Doyon K, McDarby M, Ferrell BR, Parker PA, Sanders JJ, Epstein AS, Sullivan DR, Rosenberg AR. Integrating evidence-based communication principles into routine cancer care. Support Care Cancer. 2023 Sep 8;31(10):566. doi: 10.1007/s00520-023-08020-x. PMID 37682354
- BACKGROUNDBuljan I, Tokalic R, Roguljic M, Zakarija-Grkovic I, Vrdoljak D, Milic P, Puljak L, Marusic A. Framing the numerical findings of Cochrane plain language summaries: two randomized controlled trials. BMC Med Res Methodol. 2020 May 6;20(1):101. doi: 10.1186/s12874-020-00990-4. PMID 32375659
- BACKGROUNDGainey K, Smith J, McCaffery K, Clifford S, Muscat D. Are plain language summaries published in health journals written according to instructions and health literacy principles? A systematic environmental scan. BMJ Open. 2024 Nov 27;14(11):e086464. doi: 10.1136/bmjopen-2024-086464.