NCT06762496

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 180 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Women with any type of early breast cancer (0-2A stages) will be recruited at Istituto Europeo di Oncologia (IEO). 170 patients with early breast cancer and 30 clinicians involved in the present project will directly benefit from better-provided care, an increase in patients' knowledge and management of their oncological symptoms, an improved patient-and-doctor relationship, and a reduction of hospital economic costs. Our interdisciplinary team will include breast cancer patients, oncologists, surgeons, psychologists, radiologists, , and nurses. All members of our team will play an active role in the most important phases of our data-driven project development cycle. A patient-centered approach will allow us to ensure their active participation from the design phase to the dissemination phase of the project. This present research project will be based on two different prospective studies: a first study based on patients already treated for breast cancer and a second study with patients newly diagnosed with early breast cancer. Semi structured interviews will be used in the first study, while newly diagnosed women in the second study will be asked to fill in an online battery of questionnaires in three different times (T0: one week after the first consultation; T1: a month later the first medical consultation; T2: three months later the first medical consultation) to assess the possible impact of using the Patient Decision Aids (PDA) on the doctor-patient communication and shared decision-making (SDM) process. This project will follow a multi-step approach and will be therefore divided into different developmental phases, within which specific objectives will need to be reached in order to move forward. Assessment measures throughout the protocol include: AttrakDiff; SUS, a 38-item specific questionnaire that measures satsifaction with PDA, PHQ-9, STAI, SDMQ9, Distress thermometer, EORTC-QLQ.C30, EORT-QLQ-BR23. Any further material used for qualitative assessment will be be made available upon reasonable request.

Conditions

• Breast Carcinoma
• Breast Cancer Stage I
• Breast Cancer Stage II

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-01-22
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-01-07
• Last updated: 2025-11-28

Locations

1 site across 1 country: Italy