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

Not yet recruiting

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

• Registration Number: NCT06762496
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Last Update Submitted: 2024-12-31
• Study Start: 2025-01
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of an ad hoc Patient Decision Aid (PDA)	3 months	Patients in the Intervention group will receive via mail the final version of the PDA and a battery of questionnaires.; Patients in the Control group will receive only the online link with the battery of questionnaires.; In both the experimental and the control group, questionnaires will be administered one week after the first medical consultation (T0), one month later the first medical consultation (T1), and three months later the first medical consultations (T2).; The difference between T1 and T0 and T2 and T0 will be calculated for each endpoint.

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy