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

NCT ID: NCT06762496

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-22
• Study Completion Date: 2027-01-31

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Stakeholders

physicians involved in the diagnosis and treatment decision for patients with early breast cancer (10 oncologists, 10 breast surgeons, and 10 breast radiologists specifically).

Healthcare professionals

Intervention Type: OTHER

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 randomized in this group will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires

Patients PDA group

Intervention Type: OTHER

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

Patients control group

Patients randomized in this group will receive only the online link with the battery of questionnaires.

Patients control group

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Patients PDA group

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

Intervention Type: OTHER

Patients control group

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriella Pravettoni

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gabriella Pravettoni

Role: CONTACT

gabriella.pravettoni@ieo.it

0039 02 57489731

Other Identifiers

UID 4841

Identifier Type: -

Identifier Source: org_study_id