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

European Institute of Oncology

Status: Enrolling

Conditions: Breast Cancer Stage II; Breast Cancer Stage I; Breast Carcinoma

Treatments: Other: Healthcare professionals; Other: Patients control group; Other: Patients PDA group

Study type: Observational

Funder types: Other

Identifiers

NCT06762496

UID 4841

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 3 patient groups

Stakeholders

Description:

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

Treatment:

Other: Healthcare professionals

Patients PDA group

Description:

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

Treatment:

Other: Patients PDA group

Patients control group

Description:

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

Treatment:

Other: Patients control group