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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, Italy) |
| Status | Recruiting |
| Started | January 22, 2025 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | November 28, 2025 |
| Trial ID | NCT06762496 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
- Principal investigator: Gabriella Pravettoni — European Institute of Oncology
- Study coordinator: Gabriella Pravettoni
- Email: gabriella.pravettoni@ieo.it
- Phone: 0039 02 57489731
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using tart cherry juice to prevent nerve damage from chemotherapy in breast cancer patients
This study is testing if drinking tart cherry juice can help prevent nerve damage in breast cancer patients receiving chemotherapy.
-
Capecitabine for MRD-positive, resected ER+/HER2-negative breast cancer
This Phase 2 trial tests whether taking capecitabine can help people with resected, ER-positive/HER2-negative breast cancer who still have molecular residual disease after standard therapy.
-
Adding TheraBionic P1 radiofrequency therapy to treatment for early-stage HR+ HER2- breast cancer
This study will try giving TheraBionic P1 amplitude-modulated radiofrequency therapy before surgery to see if it improves tumor response in women with early-stage, hormone receptor–positive, HER2-negative breast cancer.
-
Combining FWD1802 with CDK4/6 inhibitors or everolimus for ER+/HER2- advanced breast cancer
This trial tests whether adding FWD1802 to CDK4/6 inhibitors or everolimus helps people with ER-positive/HER2-negative unresectable locally advanced or metastatic breast cancer who have progressed on or cannot use standard therapy.
-
Using PTFE mesh for breast reconstruction in cancer patients
This study tests if using a special mesh called PTFE can help women with early-stage breast cancer have better and safer breast reconstruction compared to a traditional method.
-
Predicting how hormone therapy before surgery affects breast cancer
This study is testing how hormone therapy before surgery can help people with early-stage breast cancer and what it means for their tumors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.