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Recruiting Observational

A New Tool to Promote Patient's Engagement in Their Healthcare Process

NCT06762496 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2025-01-22
Last updated
2025-11-28

Condition(s) studied

Breast CarcinomaBreast Cancer Stage IBreast Cancer Stage II

Investigational drug(s) / intervention(s)

Healthcare professionalsPatients PDA groupPatients control group

Healthcare professionals: healthcare professionals (HCPs) targeted, including team members: we will involve 30 physicians (who are involved in the process of care towards patients with early breast cancer (10 oncologists, 10 breast surgeon, and 10 breast radiologists specifically) for the semi-structured interviews

Patients PDA group: Participants will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires

Patients control group: Participants will receive only the online link with the battery of questionnaires

Study summary

Women diagnosed with early-stage breast cancer need to make a decision about the therapeutic treatment to undertake. Since multiple factors can influence this decision, it is necessary to develop a decision-making support tool to assist them in making this choice.

Main Objective: To develop a decision-making support tool for determining the treatment to undertake for women diagnosed with early-stage breast cancer and test its effectiveness on an experimental group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Development of an ad hoc Patient Decision Aid (PDA) — 3 months
    Patients in the Intervention group will receive via mail the final version of the PDA and a battery of questionnaires. Patients in the Control group will receive only the online link with the battery of questionnaires. In both the experimental and the control group, questionnaires will be administered one week after the first medical consultation (T0), one month later the first medical consultation (T1), and three months later the first medical consultations (T2). The difference between T1 and T0 and T2 and T0 will be calculated for each endpoint.

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06762496 on ClinicalTrials.gov ↗ ← All trials in Italy