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

NCT06762496 | Recruiting

• 1 other identifier: UID 4841
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Breast Cancer Stage I; Breast Cancer Stage II

Keywords

early breast cancer; Patient Decision; engagement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

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

Patients control group

Patients randomized in this group will receive only the online link with the battery of questionnaires.

Other: Patients control group

Interventions

Healthcare professionals OTHER

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

Stakeholders

Patients PDA group OTHER

Participants will receive via mail the final version of the PDA and a Qualtrics link with a battery of questionnaires

Patients PDA group

Patients control group OTHER

Participants will receive only the online link with the battery of questionnaires

Patients control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Health Personnel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services

Study Officials

• Gabriella Pravettoni

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gabriella Pravettoni

CONTACT

0039 02 57489731; gabriella.pravettoni@ieo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2024
• First Posted: January 7, 2025
• Study Start: January 22, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 28, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Jan 2025 - Sep 2026

Locations

IT (1)