Clinical trial NCT05837533: Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients
Official title: Multicenter Study to Evaluate the Impact of a Systematized Communication Model to Increase the Knowledge of Breast Cancer Patients About Their Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Stage IV
Breast Cancer Metastatic
Communication
Lead sponsor: Medicos e Investigadores en la Lucha contra el Cancer de Mama
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: During the first half of the study, patients will be assigned to the control group where they will receive information through their usual care from their oncologist during their medical consultation. In the second half of the study, patients will be assigned to the intervention group where they will receive information through the communication model used by their oncologist during their medical consultation. In this way, the contamination of the control group with attention corresponding to the systematized communication model under study will be avoided.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Patient understanding
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Pedro Garza Garcia
country: Mexico
facility: Hospital Zambrano Hellion
state: Nuevo Leon
Study officials:
References: