Clinical trial Recruiting at 1 site Observational Ages 18 and up

Decision-making tool to help women with early breast cancer choose treatment

Official title: Development and Testing of a Patient's Decision Aid for Early Breast Cancer: a New Tool to Promote Patient's Engagement in Their Healthcare Process

Run by European Institute of Oncology · NCT06762496 · Data updated 2026-11-12

This project will test a patient decision aid to help women with early-stage breast cancer make treatment choices.

More Breast Carcinoma trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment180 (estimated)
SponsorEuropean Institute of Oncology
Academic / other
Locations1 site (Milan, Italy)
StatusRecruiting
StartedJanuary 22, 2025
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedNovember 28, 2025
Trial IDNCT06762496 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 18 or older with resectable early-stage breast cancer (stage 0–2A) who can provide informed consent and do not have significant cognitive or psychiatric impairment are ideal candidates.

Probably not a fit

Patients with advanced, unresectable or metastatic breast cancer, significant cognitive impairment, or active psychiatric/substance-use disorders likely will not benefit from this PDA.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The team will develop a patient decision aid (PDA) with input from patients, surgeons, oncologists, psychologists, radiologists, and nurses and then test its use at the European Institute of Oncology in Milan. The work has two prospective components: semi-structured interviews with previously treated patients and a prospective component where newly diagnosed patients are assigned to a PDA or a control group and complete online questionnaires at T0 (one week), T1 (one month), and T2 (three months) after the first consultation. About 170 patients and 30 clinicians will be involved, and measures will include patient knowledge, doctor–patient communication, symptom management, and hospital economic indicators. The project uses a patient-centered, data-driven design process with active patient participation from design through dissemination.

Why it matters

Potential benefit: If successful, the tool could improve patients' knowledge, support clearer treatment decisions, strengthen doctor–patient communication, and reduce some healthcare costs.

How similar studies have gone: Patient decision aids for breast cancer have been used previously and generally improve patient knowledge and decision quality, so this approach builds on existing evidence rather than being entirely novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* be 18 or older;
* have received/receive diagnosis of resectable breast cancer in the early stage;
* women treated or who will undergo oncological treatment for early breast cancer;
* demonstrate the absence of psychopathological features.
* be willing and able to provide written informed consent/assent for the trial

Exclusion Criteria:

* breast cancer patients who showed physical or psychological issues, as well as cognitive impairments that prohibited their participation in this type of study;
* neurological or psychiatric disorders that may compromise the patients' ability to take part in the study.
* Distant metastases from breast cancer or locally advanced/unresectable disease
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Where it's running

  • European Institute of Oncology
    Milan, Italy, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.