Decision-making tool to help women with early breast cancer choose treatment
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
This project will test a patient decision aid to help women with early-stage breast cancer make treatment choices.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06762496 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Italy
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.