Recruiting

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

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.

ClinicalTrials.gov IDNCT06762496

PhaseNot Applicable

Enrollment180

SponsorEuropean Institute of Oncology

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Carcinoma, Breast Cancer Stage I, Breast Cancer Stage II

About this study

Interventions

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

Primary outcomes

Development of an ad hoc Patient Decision Aid (PDA) (3 months)

Eligibility information

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

Study locations

European Institute of Oncology, Milan, Italy 20141 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.