Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837533
Status:
RECRUITING
Last Update Posted:
2023-10-18
First Post:
2023-04-19
Brief Title:
Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients
Sponsor:
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Organization:
Medicos e Investigadores en la Lucha contra el Cancer de Mama
Study Overview
Official Title:
Multicenter Study to Evaluate the Impact of a Systematized Communication Model to Increase the Knowledge of Breast Cancer Patients About Their Disease
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Both in Mexico and in the world breast cancer is the most common malignancy in women It is estimated that in 2020 282 of the new cancer cases reported in our country correspond to breast cancer which translates to 30000 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None