Non-Metastatic Breast CancerNCT07140107
Effectiveness of Original vs. AI-Generated Plain Language Summaries of Systematic Reviews
A study testing AI-generated PLS and Original PLS in people with Non-Metastatic Breast Cancer, run by University of Split, School of Medicine at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Non-Metastatic Breast Cancer
- What is being tested?
- AI-generated PLS and Original PLS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteCroatia
- Study dates
- 14 Aug 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- female patients with metastatic breast cancer.
- female patients receiving only hormonal treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site
Department of Oncology and Radiotherapy, University Hospital Split
Split, 21000
About this study
Official title: Patients' Perceptions and Comprehension of Original Versus AI-Generated Plain Language Summaries of Cochrane Oncology Systematic Reviews
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.
Read the detailed description
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.
- Conditions
- Non-Metastatic Breast Cancer
- Being tested
- AI-generated PLS, Original PLS
- Keywords
- health literacy, breast cancer, artificial intelligence, plain language summary, systematic reviews, Cochrane
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-generated PLSBehavioural
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.
Original PLSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Original PLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Immediately after reading individual PLS
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: Immediately after reading individual PLS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start14 Aug 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Non-Metastatic Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Split
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140107
- Sponsor's protocol ID
- 2181-198-03-04-25-0071
- Other IDs
- 2181-147/01-06/LJ.Z.- 25-02
- Status last verified
- Aug 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymous dataset from the study.
Publications
Hasannejadasl 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.
PubMed 36194843Seiler A, Jenewein J. Resilience in Cancer Patients. Front Psychiatry. 2019 Apr 5;10:208. doi: 10.3389/fpsyt.2019.00208. eCollection 2019.
PubMed 31024362Goerling 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.
PubMed 31474389Diefenbach 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.
PubMed 19449269Rosa 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.
PubMed 37682354Buljan 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.
PubMed 32375659Gainey 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.
PubMed 39608994Banic 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.
PubMed 36088293Zaretsky 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.
PubMed 38466307Arnold 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.
PubMed 36084384Soldato 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.
PubMed 37005952Nardin 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.
PubMed 32612947Shaikh 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.
PubMed 33305350Suto 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.
PubMed 40106236Suto 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.
PubMed 36951519
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients' Perceptions and Comprehension of Original Versus AI-Generated Plain Language Summaries of Cochrane Oncology Systematic Reviews
- ClinicalTrials.gov ID
- NCT07140107
- Acronym / sponsor ID
- 2181-198-03-04-25-0071
- Conditions
- Non-Metastatic Breast Cancer
- Keywords
- health literacy, breast cancer, artificial intelligence, plain language summary, systematic reviews, Cochrane
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Collaborators
- University Hospital of Split
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 24 Aug 2025 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients Receiving AI-generated Plain Language Summaries | Experimental | Behavioral: AI-generated PLSExperimental 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). |
| Patients Receiving Original Plain Language Summaries | Active comparator | Behavioral: Original PLSActive 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- female patients with histologically confirmed non-metastatic breast cancer currently undergoing chemotherapy or radiotherapy:
- patients need to be able to read and understand Croatian.
Key exclusion criteria (2 listed)
- female patients with metastatic breast cancer.
- female patients receiving only hormonal treatment.
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 |
|---|---|---|
| AI-generated PLSReading 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. | Behavioural | Patients Receiving AI-generated Plain Language Summaries |
| Original PLSReading 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. | Behavioural | Patients Receiving Original Plain Language Summaries |
Primary outcome
Patients' level of intention for changing their behavior
Time frame: Immediately after reading individual PLS
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).
4 secondary outcomes
Patients' comprehension of the information presented in the summary
Time frame: Immediately after reading individual PLS
Patients' level of trust in the information presented
Time frame: Immediately after reading individual PLS
Patients' level of perceived clarity in the information
Time frame: Immediately after reading individual PLS
Patient's level of confidence in their decision to change behavior
Time frame: Immediately after reading individual PLS
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Background: PubMed 36194843Hasannejadasl 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.
- Background: PubMed 31024362Seiler A, Jenewein J. Resilience in Cancer Patients. Front Psychiatry. 2019 Apr 5;10:208. doi: 10.3389/fpsyt.2019.00208. eCollection 2019.
- Background: PubMed 31474389Goerling 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.
- Background: PubMed 19449269Diefenbach 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.
- Background: PubMed 37682354Rosa 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.
- Background: PubMed 32375659Buljan 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.
- Background: PubMed 39608994Gainey 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.
- Background: PubMed 36088293Banic 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.
- Background: PubMed 38466307Zaretsky 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.
- Background: PubMed 36084384Arnold 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.
- Background: PubMed 37005952Soldato 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.
- Background: PubMed 32612947Nardin 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.
- Individual participant dataSharing planned: Yes. Anonymous dataset from the study.
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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.
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 study testing AI-generated PLS and Original PLS in people with Non-Metastatic Breast Cancer, run by University of Split, School of Medicine at 1 site in Croatia.
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 5 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: enrolling by invitation, as of the sponsor's last update on 24 Aug 2025. 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 Croatia. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Patients' level of intention for changing their behavior (time frame: Immediately after reading individual PLS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07140107, which also lists 18 linked publications.
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 24 Aug 2025.