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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое Patients PDA group
  Participants will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires
• Другое Patients control group
  Participants will receive only the online link with the battery of questionnaires

Первичные конечные точки

• Development of an ad hoc Patient Decision Aid (PDA) [Срок оценки: 3 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Италия · 1 центр

• European Institute of Oncology — Milan

Публикации

• 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

Идентификаторы

NCT: NCT06762496 · UID 4841

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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