Prostate Cancer (Adenocarcinoma)Phase 2NCT07568444
Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence (BRIDGE AI 3)
A Phase 2 study testing Pub2Post in people with Prostate Cancer (Adenocarcinoma) and Bladder Cancer, run by University of Southern California at 1 site in United States.
Trial summary
This trial tests if AI can help make medical info clear and readable. Many patients struggle to find medical informations that easy to read and understand from verified medical sources. The study tests if an AI tool can assist health providers to craft clear text for patients more fast than what they do now. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Bladder Cancer, Kidney Cancers
- What is being tested?
- Pub2Post
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2025to 27 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Corresponding authors who have been published in the top 10 journals of urology and medicine
- All genders
- Any profession
- 18+ years of age
Who cannot join
- Anyone under the age of 18
- Participants that have not published in the top 10 journals of urology and medicine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 91100
About this study
Official title: Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence: A Randomized Controlled Trial (BRIDGE AI 3)
This trial tests if AI can help make medical info clear and readable. Many patients struggle to find medical informations that easy to read and understand from verified medical sources. The study tests if an AI tool can assist health providers to craft clear text for patients more fast than what they do now. Health providers are split at random into two groups-one uses the AI tool and one does not. The trial tests how clear the text is, how correct it is, and how much time is saved. The aim is to see if AI can close the gap between complex research and what patients can grasp.
Read the detailed description
This study evaluates whether a generative artificial intelligence (AI) tool can improve the readability and accessibility of lay summaries derived from scientific medical abstracts. Many patients encounter difficulty understanding medical literature due to technical language and complexity, which can limit informed decision-making and engagement with healthcare information.
The BRIDGE-AI (Provider Perspective) initiative aims to address this gap by enabling healthcare professionals and researchers to generate patient-friendly summaries of scientific content using AI-assisted tools. The intervention leverages a generative AI framework (pub2people) designed to translate complex medical terminology into language that is understandable to a general audience.
In this randomized controlled study, participants with experience in scientific publishing will be assigned to either an AI-assisted group or a control group using conventional methods. Participants will be asked to transform scientific abstracts into layperson-friendly summaries. The study compares AI-assisted and manually generated outputs in terms of readability, accuracy, and efficiency.
The primary objective is to determine whether AI-assisted generation improves the readability of lay summaries compared to standard approaches. Secondary objectives include evaluating the accuracy of AI-generated summaries relative to source material and assessing potential time savings associated with AI use.
This study contributes to ongoing efforts to improve health communication by evaluating scalable tools that may enhance the translation of complex medical information into patient-accessible formats.
- Being tested
- Pub2Post
- Keywords
- Bridge AI, Generative Artificial Intelligence, GAI
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma, Urinary Bladder Neoplasms, Kidney Neoplasms, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pub2PostOther
Pub2Post, a generative artificial intelligence agent which helps in drafting the layperson abstracts and summaries
| Study group | Role | What they receive |
|---|---|---|
| Gold Standard | No intervention | Not described |
| Pub2Post | Experimental | Not described Receives: Other: Pub2Post |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readability Change
Flesch Reading Ease Score
Description: Measures text readability based on sentence length and word syllables.
Scale: 0 to 100 Interpretation: Higher scores indicate easier readability (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Flesch-Kincaid Grade Level Description: Estimates U.S. school grade level required to understand the text. Scale: Typically ranges from ~0 to 18+ Interpretation: Lower scores indicate easier readability (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Gunning Fog Index Description: Estimates years of formal education needed to understand the text on first reading.
Scale: Typically 0 to 20+ Interpretation: Lower scores indicate easier readability (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
SMOG Index (Simple Measure of Gobbledygook) Description: Estimates years of education required to comprehend the text. Scale: Typically 0 to 20+ Interpretation: Lower scores indicate easier readability (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Coleman-Liau Index Description: Readability formula based on characters per word and sentence length.
Scale: Typically 0 to 18+ (grade level equivalent) Interpretation: Lower scores indicate easier readability (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Readability Change
Automated Readability Index (ARI) Description: Estimates grade level required for comprehension using characters and word counts.
Scale: Typically 0 to 14+ Interpretation: Lower scores indicate easier readability (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Secondary outcomes (12)
Time Saving
To evaluate the time savings achieved by using generative AI compared to traditional methods for generating layperson abstracts and summaries. Time will be recorded in hours, minutes, and seconds. We will collect and compare the total time spent drafting the complete layperson abstract and summaries, as well as the time spent on each individual section - background, methods, results, conclusion, and short summaries. The comparison will be made between summaries created by humans alone versus those created with GAI assistance.
Time will be reported in minutes
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Accuracy Score of Layperson Abstract Sections Description: Degree to which each section (Background, Methods, Results, Conclusion, Short Summary) reflects key information from the original scientific abstract.
Scale: 5-point Likert scale (1 = very inaccurate, 5 = highly accurate) Assessment Method: Two independent reviewers score each section Interpretation: Higher scores indicate better accuracy (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Completeness Score of Layperson Abstract Sections Description: Extent to which essential information from the original abstract is included in each section.
Scale: 5-point Likert scale (1 = very incomplete, 5 = fully complete) Assessment Method: Two independent reviewers evaluate each section. Interpretation: Higher scores indicate greater completeness (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Clarity Score for Layperson Readability Description: Evaluates simplicity, avoidance of jargon, and coherence for lay audiences.
Scale: 5-point Likert scale (1 = very unclear, 5 = very clear and understandable) Assessment Method: Two independent reviewers evaluate each section. Interpretation: Higher scores indicate better clarity (better outcome).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Section-Level Correctness Rate Description: Proportion of sections rated as "correct," defined as receiving scores ≥4 from both reviewers on accuracy, completeness, and clarity simultaneously.
Scale: 0 to 1 (proportion) or 0% to 100% Interpretation: Higher values indicate better overall section quality.
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Hallucination Rate Description: Frequency of false or misleading content in generated layperson abstracts, defined as information not supported by the original abstract.
Scale: Proportion of sections or documents containing hallucinations (0 to 1 or %) Assessment Method: Evaluated separately by reviewers using predefined criteria. Interpretation: Lower values indicate better performance (fewer hallucinations).
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Perceived Task Difficulty
Description: Participant-reported difficulty of completing the lay abstract summarization task.
Scale: 5-point Likert scale (1 = very easy, 5 = very difficult) (adjust anchors if different in your instrument) Assessment Timing: Immediately after task completion Interpretation: Lower scores indicate less perceived difficulty (better outcome)
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
Perceived Task Duration
Description: Participant perception of time required to complete the task. Scale: 5-point Likert scale (1 = very short, 5 = very long) Assessment Timing: Post-task Interpretation: Lower scores indicate shorter perceived duration (better outcome)
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
Perceived Helpfulness of the intervention
Description: Participant-reported usefulness of the generative AI tool in assisting lay abstract creation.
Scale: 5-point Likert scale (1 = not helpful at all, 5 = extremely helpful) Assessment Timing: Post-task Interpretation: Higher scores indicate greater perceived helpfulness (better outcome)
Measured: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
System Usability Scale (SUS) Score
Description: Standardized assessment of system usability using the System Usability Scale.
Scale: 0 to 100 Interpretation: Higher scores indicate better usability
- 70: acceptable usability
- 90: superior usability
Measured: Immediately after completing the system/task (post-use assessment)
Perceived Usefulness (Technology Acceptance Model)
Description: Degree to which participants believe the GAI tool enhances task performance.
Scale: Likert scale (typically 1-5 or 1-7; specify exact instrument version) Interpretation: Higher scores indicate greater perceived usefulness (better outcome)
Measured: Immediately after completing the system/task (post-use assessment)
Perceived Ease of Use (Technology Acceptance Model)
Description: Degree to which participants find the GAI tool easy to use. Scale: Likert scale (typically 1-5 or 1-7; must match instrument used) Interpretation: Higher scores indicate greater ease of use (better outcome)
Measured: Immediately after completing the system/task (post-use assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start16 Jan 2025
- Primary completion22 Jan 2025
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group randomized controlled trial in which participants are assigned in a 1:1 ratio to either an AI-assisted intervention arm or a control arm using conventional methods. In the intervention arm, participants use a generative AI tool to produce lay summaries from scientific abstracts. In the control arm, participants generate lay summaries without AI assistance. Outcomes are assessed post-task for each participant. No crossover between arms is planned.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Cacciamani, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07568444
- Sponsor's protocol ID
- UP-24-01142
- Status last verified
- May 2026
- First submitted
- 12 Mar 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Readability of Lay Abstracts and Summaries for Medical Knowledge Using Generative Artificial Intelligence: A Randomized Controlled Trial (BRIDGE AI 3)
- ClinicalTrials.gov ID
- NCT07568444
- Acronym / sponsor ID
- UP-24-01142
- Keywords
- Bridge AI, Generative Artificial Intelligence, GAI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 16 Jan 2025 (actual)
- Primary completion
- 22 Jan 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial tests if AI can help make medical info clear and readable. Many patients struggle to find medical informations that easy to read and understand from verified medical sources. The study tests if an AI tool can assist health providers to craft clear text for patients more fast than what they do now. Health providers are split at random into two groups-one uses the AI tool and one does not. The trial tests how clear the text is, how correct it is, and how much time is saved. The aim is to see if AI can close the gap between complex research and what patients can grasp.
Detailed description
This study evaluates whether a generative artificial intelligence (AI) tool can improve the readability and accessibility of lay summaries derived from scientific medical abstracts. Many patients encounter difficulty understanding medical literature due to technical language and complexity, which can limit informed decision-making and engagement with healthcare information.
The BRIDGE-AI (Provider Perspective) initiative aims to address this gap by enabling healthcare professionals and researchers to generate patient-friendly summaries of scientific content using AI-assisted tools. The intervention leverages a generative AI framework (pub2people) designed to translate complex medical terminology into language that is understandable to a general audience.
In this randomized controlled study, participants with experience in scientific publishing will be assigned to either an AI-assisted group or a control group using conventional methods. Participants will be asked to transform scientific abstracts into layperson-friendly summaries. The study compares AI-assisted and manually generated outputs in terms of readability, accuracy, and efficiency.
The primary objective is to determine whether AI-assisted generation improves the readability of lay summaries compared to standard approaches. Secondary objectives include evaluating the accuracy of AI-generated summaries relative to source material and assessing potential time savings associated with AI use.
This study contributes to ongoing efforts to improve health communication by evaluating scalable tools that may enhance the translation of complex medical information into patient-accessible formats.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a parallel-group randomized controlled trial in which participants are assigned in a 1:1 ratio to either an AI-assisted intervention arm or a control arm using conventional methods. In the intervention arm, participants use a generative AI tool to produce lay summaries from scientific abstracts. In the control arm, participants generate lay summaries without AI assistance. Outcomes are assessed post-task for each participant. No crossover between arms is planned.
| Arm | Type | Receives |
|---|---|---|
| Gold Standard | No intervention | – |
| Pub2Post | Experimental | Other: Pub2Post |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Corresponding authors who have been published in the top 10 journals of urology and medicine
- All genders
- Any profession
- 18+ years of age
Key exclusion criteria (2 listed)
- Anyone under the age of 18
- Participants that have not published in the top 10 journals of urology and medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pub2PostPub2Post, a generative artificial intelligence agent which helps in drafting the layperson abstracts and summaries | Other | Pub2Post |
Primary outcome
Readability Change
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Flesch Reading Ease Score Description: Measures text readability based on sentence length and word syllables. Scale: 0 to 100 Interpretation: Higher scores indicate easier readability (better outcome).
Readability Change
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Flesch-Kincaid Grade Level Description: Estimates U.S. school grade level required to understand the text. Scale: Typically ranges from ~0 to 18+ Interpretation: Lower scores indicate easier readability (better outcome).
Readability Change
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Gunning Fog Index Description: Estimates years of formal education needed to understand the text on first reading. Scale: Typically 0 to 20+ Interpretation: Lower scores indicate easier readability (better outcome).
Readability Change
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
SMOG Index (Simple Measure of Gobbledygook) Description: Estimates years of education required to comprehend the text. Scale: Typically 0 to 20+ Interpretation: Lower scores indicate easier readability (better outcome).
Readability Change
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Coleman-Liau Index Description: Readability formula based on characters per word and sentence length. Scale: Typically 0 to 18+ (grade level equivalent) Interpretation: Lower scores indicate easier readability (better outcome).
Readability Change
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Automated Readability Index (ARI) Description: Estimates grade level required for comprehension using characters and word counts. Scale: Typically 0 to 14+ Interpretation: Lower scores indicate easier readability (better outcome).
12 secondary outcomes
Time Saving
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Correctness and meaning retention
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.
Perceived Task Difficulty
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
Perceived Task Duration
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
Perceived Helpfulness of the intervention
Time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment
System Usability Scale (SUS) Score
Time frame: Immediately after completing the system/task (post-use assessment)
Perceived Usefulness (Technology Acceptance Model)
Time frame: Immediately after completing the system/task (post-use assessment)
Perceived Ease of Use (Technology Acceptance Model)
Time frame: Immediately after completing the system/task (post-use assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pub2Post in people with Prostate Cancer (Adenocarcinoma) and Bladder Cancer, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readability Change (time frame: The assessment will be conducted immediately after the study closes, which will occur 4 weeks after enrollment.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.