Effectiveness of Original vs. AI-Generated Plain Language Summaries of Systematic Reviews

NCT07140107 | Enrolling By Invitation

• 2 other identifiers: 2181-198-03-04-25-00712181-147/01-06/LJ.Z.- 25-02
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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

Non-Metastatic Breast Cancer

Keywords

health literacy; breast cancer; artificial intelligence; plain language summary; systematic reviews; Cochrane

Outcome Measures

Primary Outcomes (1)

• Patients' level of intention for changing their behavior

  Patients' level of intention for changing their behavior and start applying the interventions described in the summary, measured on a visual analogue scale (VAS) ranging from 0 to 100 (do not agree at all to 100 fully agree).

  Immediately after reading individual PLS

Secondary Outcomes (4)

• Patients' comprehension of the information presented in the summary

  Immediately after reading individual PLS

• Patients' level of trust in the information presented

  Immediately after reading individual PLS

• Patients' level of perceived clarity in the information

  Immediately after reading individual PLS

• Patient's level of confidence in their decision to change behavior

  Immediately after reading individual PLS

Study Arms (2)

Patients Receiving AI-generated Plain Language Summaries

EXPERIMENTAL

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).

Behavioral: AI-generated PLS

Patients Receiving Original Plain Language Summaries

ACTIVE COMPARATOR

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).

Behavioral: Original PLS

Interventions

AI-generated PLS BEHAVIORAL

Reading AI-generated Plain Language Summaries of two Cochrane systematic reviews covering the same two evidence-based topics: exercise during adjuvant therapy and psychological interventions for non-metastatic breast cancer.

Patients Receiving AI-generated Plain Language Summaries

Original PLS BEHAVIORAL

Reading original Plain Language Summaries of two Cochrane systematic reviews covering the same two evidence-based topics: exercise during adjuvant therapy and psychological interventions for non-metastatic breast cancer.

Patients Receiving Original Plain Language Summaries

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female patients with histologically confirmed non-metastatic breast cancer currently undergoing chemotherapy or radiotherapy:
• neoadjuvant chemotherapy (with or without immunotherapy or antiHER2 therapy),
• adjuvant chemotherapy (with or without immunotherapy or antiHER2 therapy),
• adjuvant radiotherapy (including local and locoregional radiation treatment with possible radiotherapy boost where indicated).
• patients need to be able to read and understand Croatian.

You may not qualify if:

• female patients with metastatic breast cancer.
• female patients receiving only hormonal treatment.

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• University Hospital of Split: collaborator

Study Sites (1)

Department of Oncology and Radiotherapy, University Hospital Split

Split, 21000, Croatia

Location

Related Publications (18)

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• Gainey 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.

  PMID: 39608994 BACKGROUND

• Banic A, Fidahic M, Suto J, Roje R, Vuka I, Puljak L, Buljan I. Conclusiveness, linguistic characteristics and readability of Cochrane plain language summaries of intervention reviews: a cross-sectional study. BMC Med Res Methodol. 2022 Sep 10;22(1):240. doi: 10.1186/s12874-022-01721-7.

  PMID: 36088293 BACKGROUND

• Zaretsky J, Kim JM, Baskharoun S, Zhao Y, Austrian J, Aphinyanaphongs Y, Gupta R, Blecker SB, Feldman J. Generative Artificial Intelligence to Transform Inpatient Discharge Summaries to Patient-Friendly Language and Format. JAMA Netw Open. 2024 Mar 4;7(3):e240357. doi: 10.1001/jamanetworkopen.2024.0357.

  PMID: 38466307 BACKGROUND

• Arnold M, Morgan E, Rumgay H, Mafra A, Singh D, Laversanne M, Vignat J, Gralow JR, Cardoso F, Siesling S, Soerjomataram I. Current and future burden of breast cancer: Global statistics for 2020 and 2040. Breast. 2022 Dec;66:15-23. doi: 10.1016/j.breast.2022.08.010. Epub 2022 Sep 2.

  PMID: 36084384 BACKGROUND

• Soldato D, Arecco L, Agostinetto E, Franzoi MA, Mariamidze E, Begijanashvili S, Brunetti N, Spinaci S, Solinas C, Vaz-Luis I, Di Meglio A, Lambertini M. The Future of Breast Cancer Research in the Survivorship Field. Oncol Ther. 2023 Jun;11(2):199-229. doi: 10.1007/s40487-023-00225-8. Epub 2023 Apr 1.

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• Nardin S, Mora E, Varughese FM, D'Avanzo F, Vachanaram AR, Rossi V, Saggia C, Rubinelli S, Gennari A. Breast Cancer Survivorship, Quality of Life, and Late Toxicities. Front Oncol. 2020 Jun 16;10:864. doi: 10.3389/fonc.2020.00864. eCollection 2020.

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• Shaikh H, Bradhurst P, Ma LX, Tan SYC, Egger SJ, Vardy JL. Body weight management in overweight and obese breast cancer survivors. Cochrane Database Syst Rev. 2020 Dec 11;12(12):CD012110. doi: 10.1002/14651858.CD012110.pub2.

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• Suto Pavicic J, Marusic A, Buljan I. Using ChatGPT to Improve the Presentation of Plain Language Summaries of Cochrane Systematic Reviews About Oncology Interventions: Cross-Sectional Study. JMIR Cancer. 2025 Mar 19;11:e63347. doi: 10.2196/63347.

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• Suto J, Marusic A, Buljan I. Linguistic analysis of plain language summaries and corresponding scientific summaries of Cochrane systematic reviews about oncology interventions. Cancer Med. 2023 May;12(9):10950-10960. doi: 10.1002/cam4.5825. Epub 2023 Mar 23.

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• Stephan D, Bertsch AS, Schumacher S, Puladi B, Burwinkel M, Al-Nawas B, Kammerer PW, Thiem DG. Improving Patient Communication by Simplifying AI-Generated Dental Radiology Reports With ChatGPT: Comparative Study. J Med Internet Res. 2025 Jun 9;27:e73337. doi: 10.2196/73337.

  PMID: 40489773 BACKGROUND

• Furmaniak AC, Menig M, Markes MH. Exercise for women receiving adjuvant therapy for breast cancer. Cochrane Database Syst Rev. 2016 Sep 21;9(9):CD005001. doi: 10.1002/14651858.CD005001.pub3.

  PMID: 27650122 BACKGROUND

• Jassim GA, Whitford DL, Hickey A, Carter B. Psychological interventions for women with non-metastatic breast cancer. Cochrane Database Syst Rev. 2015 May 28;(5):CD008729. doi: 10.1002/14651858.CD008729.pub2.

  PMID: 26017383 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: August 14, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Anonymous dataset will be available with the publication of the study.
• Access Criteria: Anyone

Locations

CR (1)