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

NCT ID: NCT05837533

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-17
• Study Completion Date: 2024-11-16

Brief Summary

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.

Conditions

Breast Cancer Stage IV; Breast Cancer Metastatic; Communication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Communication model

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medicos e Investigadores en la Lucha contra el Cancer de Mama

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital Zambrano Hellion

San Pedro Garza García, Nuevo León, Mexico

Countries

Mexico

Other Identifiers

EC-COMUNICACION

Identifier Type: -

Identifier Source: org_study_id