A New Tool to Promote Patient's Engagement in Their Healthcare Process
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healthcare professionals, Patients PDA group, Patients control group.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, Breast Cancer Stage I, Breast Cancer Stage II. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Development of an ad hoc Patient Decision Aid (PDA) [Time frame: 3 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- European Institute of Oncology — Milan
Publications
- Sdinami S, Sebri V, Monzani D, Zagami P, Criscitiello C, Grasso R, Bagnardi V, Curigliano G, Pravettoni G. Protocol for the development and testing of a web-based patient decision aid for early-stage breast cancer patients within a cancer centre care: a mixed-method approach. BMJ Open. 2026 Feb 24;16(2):e107401. doi: 10.1136/bmjopen-2025-107401. PMID 41734922
Identifiers
NCT: NCT06762496 · UID 4841