RecruitingNCT06762496

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

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


Sponsor

European Institute of Oncology

Enrollment

180 participants

Start Date

Jan 22, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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

Interventions

OTHERHealthcare 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

OTHERPatients PDA group

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

OTHERPatients control group

Participants will receive only the online link with the battery of questionnaires


Locations(1)

European Institute of Oncology

Milan, Italy, Italy

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NCT06762496


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