Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients

Multicenter Study to Evaluate the Impact of a Systematized Communication Model to Increase the Knowledge of Breast Cancer Patients About Their Disease

Both in Mexico and in the world, breast cancer is the most common malignancy in women. It is estimated that in 2020, 28.2% of the new cancer cases reported in our country correspond to breast cancer, which translates to 30,000 new cases. In addition, it is relevant to mention that approximately 12% of Mexican patients are diagnosed with stage IV breast cancer and it is estimated that 20-30% of women with early stage cancer will have a distant recurrence of the disease. Thus, about 40% of patients will find themselves in a metastatic stage at some point in their breast cancer journey.

Various studies, including Mexico, report that only half of patients with metastatic breast cancer are aware that their disease is not curable, 31% say they are not sure, and 17% think it is curable. Likewise, 58% considered that they did not have enough knowledge to actively participate in conversations about their therapeutic options, which means that 40% reported difficulty talking about treatments with their doctors. This has shown that there are suboptimal levels of knowledge information on curability, treatment objectives and prognosis of their condition in patients with metastatic breast cancer. This lack of understanding is alarming given that a general understanding of the disease is crucial for informed decision making and adherence to cancer treatment.

Due to these alarming results, we seek to recruit women ≥18 years of age who are candidates to start first- or second-line treatment for de novo or recurrent metastatic breast cancer from various hospital centers in the country with public and private coverage, including Hospital Zambrano Hellion TecSalud as coordinating center in Nuevo León. The objective will be to evaluate whether a systematized communication model for patients with metastatic breast cancer allows increasing knowledge about the non-curative nature of treatment, compared to usual care.

Study Overview

• Status: Completed
• Conditions: Communication; Breast Cancer Stage IV; Breast Cancer Metastatic
• Intervention / Treatment: Other: Communication model

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66278
      • Hospital Zambrano Hellion

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of de novo or recurrent metastatic breast cancer
• Candidate to start the first or second line of treatment for metastatic breast cancer

Exclusion Criteria:

• Receipt of a line of treatment for metastatic breast cancer posterior to the second line

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Patients will receive information about their diagnosis, treatment and/or prognosis through the systematic communication model under study used by their oncologist during their medical consultation.	Other: Communication model; During the medical consultation of each patient assigned to the intervention group, the oncologist will use the systematic communication model for patients with metastatic breast cancer. For this, the oncologist will follow the conversation guide for patients with metastatic breast cancer, which will allow directing the conversation towards information about the patient's diagnosis, treatment and prognosis. The guide consists of a series of steps and questions to be asked to the patient in order to explore her understanding of her disease and her information preferences, as well as to facilitate the oncologist providing said information to the patient. The responses to each item in the guide will be electronically documented by the oncologist.
No Intervention: Control group; Patients will receive information about their diagnosis, treatment and/or prognosis through their usual care provided by their oncologist during their medical consultation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient understanding	Evaluate whether a systematic communication model for patients with metastatic breast cancer increases patients' understanding about the non-curative nature of treatment, compared to usual care. Understanding will be measured with the "Knowledge questionnaire" consisting of the Prognosis and Treatment Perceptions Questionnaire (PTPQ) questions, which explore patients' beliefs about their possibility of cure and the main objective of their treatment, their perception of the importance and usefulness of knowing their prognosis, their information preferences, as well as their satisfaction with the quality of the information received. Additionally, the research group developed specific questions that are of interest for this study to assess participants' perception of the usefulness of the information received through the systematic communication model, as well as their use of the information materials provided and their degree of satisfaction with them.	7 days

Collaborators and Investigators

• Sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2023
• Primary Completion (Actual): November 16, 2024
• Study Completion (Actual): November 16, 2024

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: EC-COMUNICACION

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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