Breast Cancer Stage IVNCT05837533
Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients
A study testing Communication model in people with Breast Cancer Stage IV and Breast Cancer Metastatic, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Stage IV, Breast Cancer Metastatic, Communication
- What is being tested?
- Communication model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteMexico
- Study dates
- 17 May 2023to 16 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of de novo or recurrent metastatic breast cancer
- Candidate to start the first or second line of treatment for metastatic breast cancer
Who cannot join
- Receipt of a line of treatment for metastatic breast cancer posterior to the second line
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Zambrano Hellion
San Pedro Garza García, Nuevo León, 66278
About this study
Official title: 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.
- Being tested
- Communication model
- Medical subject headings
- Breast Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication modelOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: Communication model |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start17 May 2023
- Primary completion16 Nov 2024
- Study completion16 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de Mama
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837533
- Sponsor's protocol ID
- EC-COMUNICACION
- Status last verified
- Feb 2025
- First submitted
- 19 Apr 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study to Evaluate the Impact of a Systematized Communication Model to Increase the Knowledge of Breast Cancer Patients About Their Disease
- ClinicalTrials.gov ID
- NCT05837533
- Acronym / sponsor ID
- EC-COMUNICACION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medicos e Investigadores en la Lucha contra el Cancer de MamaUniversity, hospital or other
- Study start
- 17 May 2023 (actual)
- Primary completion
- 16 Nov 2024 (actual)
- Study completion
- 16 Nov 2024 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Communication modelPatients 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. |
| Control group | No intervention | –Patients will receive information about their diagnosis, treatment and/or prognosis through their usual care provided by their oncologist during their medical consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of de novo or recurrent metastatic breast cancer
- Candidate to start the first or second line of treatment for metastatic breast cancer
Key exclusion criteria (1 listed)
- Receipt of a line of treatment for metastatic breast cancer posterior to the second line
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communication modelDuring 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. | Other | Intervention group |
Primary outcome
Patient understanding
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication model in people with Breast Cancer Stage IV and Breast Cancer Metastatic, run by Medicos e Investigadores en la Lucha contra el Cancer de Mama at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient understanding (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.