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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma; Breast Cancer Stage I; Breast Cancer Stage II
• Intervention / Treatment: Other: Healthcare professionals; Other: Patients PDA group; Other: Patients control 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.

• Study Type: Observational
• Enrollment (Estimated): 180

Contacts and Locations

• Study Contact: Name: Gabriella Pravettoni; Phone Number: 0039 02 57489731; Email: gabriella.pravettoni@ieo.it

Study Locations

• Italy
  • Italy
    • Milan, Italy, Italy, 20141
      • Recruiting
      • European Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stakeholders; physicians involved in the diagnosis and treatment decision for patients with early breast cancer (10 oncologists, 10 breast surgeons, and 10 breast radiologists specifically).	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
Patients PDA group; Participants randomized in this group will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires	Other: Patients PDA group; Participants will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires
Patients control group; Patients randomized in this group will receive only the online link with the battery of questionnaires.	Other: Patients control group; Participants will receive only the online link with the battery of questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Development of an ad hoc Patient Decision Aid (PDA)	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.	3 months

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Gabriella Pravettoni, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: December 31, 2024
• First Submitted That Met QC Criteria: December 31, 2024
• First Posted (Actual): January 7, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: early breast cancer; engagement; Patient Decision
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Facilities Workforce and Services; Health Personnel
• Other Study ID Numbers: UID 4841

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Dissemination of results will follow typical academic pathways, such as conference abstracts and peer-reviewed journals
• IPD Sharing Time Frame: Jan 2025 - Sep 2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No