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

Not Applicable

Completed

• Conditions: Breast Cancer Stage IV; Breast Cancer Metastatic; Communication
• Interventions: Other: Communication model

• Registration Number: NCT05837533
• Lead Sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-19
• Study First Submitted QC: 2023-04-28
• Study First Posted: 2023-05-01
• Study Start: 2023-05-17
• Primary Completion: 2024-11-16
• Study Completion: 2024-11-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention group	Communication model	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.

Primary Outcome Measures

Name	Time	Method
Patient understanding	7 days	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.

Trial Locations

Locations (1)

Hospital Zambrano Hellion; 🇲🇽 San Pedro Garza Garcia, Nuevo Leon, Mexico