Clinical trial NCT06762496: A New Tool to Promote Patient's Engagement in Their Healthcare Process
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Carcinoma
Breast Cancer Stage I
Breast Cancer Stage II
Keywords: early breast cancer
Patient Decision
engagement
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Number of 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. Moreover, about 10-12 professionals will take part in the steering committee.

Number of Patients affected: we will involve patients with early breast cancer for a total of 170 participants, considering all phases of the present project.

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.

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

Primary outcomes:
measure: Development of an ad hoc Patient Decision Aid (PDA)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Gabriella Pravettoni
role: PRINCIPAL_INVESTIGATOR
References: