An interventional study of AI-generated PLS and Original PLS in Non-Metastatic Breast Cancer, sponsored by University of Split, School of Medicine. Enrolling by invitation at 1 site in Croatia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Supportive care
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.
Studies show that Plain Language Summaries (PLS), which are intended to improve accessibility to health information for laypeople, are lacking in terms of comprehension, readability, and user engagement. Further empirical research is needed to evaluate the comparative effectiveness of AI-generated summaries versus original Plain Language Summaries. This study, conducted at the Department of Oncology and Radiotherapy at the University Hospital of Split aims to explore whether large language models (LLMs), such as ChatGPT, can be leveraged to provide summaries of complex medical content, as those found in systematic reviews, to be more streamlined and adapted for laypeople. The prospective, randomized, single-center, parallel group, double-blind, controlled trial focuses specifically on patients diagnosed with non-metastatic breast cancer, histologically confirmed, and aims to help them make more evidence-based medical decisions regarding their health and recovery. The study's primary objective is to analyze patients' level of intention for changing their behavior and start applying the interventions described in the summary. The level of intention to change behavior will be measured using a visual analog scale ranging from 0 to 100 (0 - do not agree at all and 100 - fully agree). The secondary outcomes are patients' level of understanding calculated by the score received on a five-question knowledge survey (5 as a maximum score), the level of trust in (range 0-100) and clarity of (range 0-100) the information presented in the PLS, and their confidence in their decision to change behavior (range 0-100). The survey is based on the information presented in the PLS and the questions focus on patients' understanding of the benefits and risks of the intervention as well as the quality of evidence described in the systematic reviews. Recruitment for this study will take place over 6 months. Patients will be invited to participate in the study before or after their routine oncology appointment. The participants will read two summaries from two respective Cochrane reviews: exercise during adjuvant therapy and psychological interventions for non-metastatic breast cancer. They will then take the brief survey that tests the impact and likelihood of applying the recommendations described in the summary and their overall understanding of the medical information discussed in the reviews. The study includes female adult oncology patients diagnosed with non-metastatic breast cancer, histologically confirmed, following a modality of the treatment, which includes one or more of the following: 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). Since participants in this study are limited to reading material and completing a survey, the study is non-invasive in nature and poses low-risk. Data will be analyzed using descriptive statistics to summarize participant characteristics and assess baseline comparability between the two study arms.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 130 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Split, School of Medicine is the lead sponsor of 51 studies on the registry; 17 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
female patients with confirmed non- breast cancer currently undergoing chemotherapy or radiotherapy:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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' 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).
Time frame: Immediately after reading individual PLS
Patients' comprehension of the information presented in the summary
Patients' level of understanding of the information presented in the summaries calculated by the score received on a five-question knowledge survey (score range 0-5).
Time frame: Immediately after reading individual PLS
Patients' level of trust in the information presented
Patients' level of trust in the information presented in the summaries, measured on a VAS (range 0-100).
Time frame: Immediately after reading individual PLS
Patients' level of perceived clarity in the information
Patients' level of perceived clarity of the information presented in the summaries, measured on a VAS (range 0-100).
Time frame: Immediately after reading individual PLS
Patient's level of confidence in their decision to change behavior
Patients' level of confidence in the decision to change behavior, measured on a VAS (range 0-100)
Time frame: Immediately after reading individual PLS
Plan to share: Yes — Anonymous dataset from the study.
Supporting information: Study protocol, Clinical study report
Time frame: Anonymous dataset will be available with the publication of the study.
Access criteria: Anyone
Started Aug 2025 (actual). Primary completion is estimated for Feb 2026, 5 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 5 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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University of Split, School of Medicine