Breast Cancer FemaleEFBCancerNCT03831308
Evaluating and Following Breast Cancer Patients in a Better Way
An observational study of Breast Cancer Female, run by Centro Hospitalar Lisboa Ocidental.
Trial summary
The current observational study aims at analysing current semiology on breast cancer patients aiming at noting indicators and signs with significant relationship with the disease outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- clinical and physical assessment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2019to 31 Dec 2020
- Phase
- Observational
- 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
Study population: women with breast cancer
Who may be able to join
- women
- age > 18y
- diagnosed with breast cancer
Who cannot join
- men
- informed consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluating, Following, and Supporting Breast Cancer Patients in a Better Way
The current observational study aims at analysing current semiology on breast cancer patients aiming at noting indicators and signs with significant relationship with the disease outcomes.
To reach the primary objective, of identifying most prominent indicators and signs, a study group of at least 100 female patients with breast cancer diagnosis will be recruited to participate voluntarily. The study group will include at least 20 patients with metastatic cancer and 30 patients with indication to adjuvant chemotherapy. Their physical activity habits and lifestyle will be noted. The observational study will consist in the periodic registration of the overall physical and psychological condition. The variables and tests below will be measured and registered, periodically:
Read more
- periodical assessment of the quality of life
- periodical assessment of the fitness status of the subjects
- assessment of changes in bone density/progression of osteoporosis
- assessment of changes in cognitive function
- assessment of sleep disorders
The collected results will be statistically analysed, in order to:
- Identify variables that are statistically significantly different from expected values
- quantify statistically significant differences, whenever possible
The results will be used to better describe the breast cancer population
Read the detailed description
Breast Cancer treatment is expected to have the best outcome when adapted to the patients' health, and physical condition. The investigators aim at contributing to produce an improved algorithm to evaluate breast cancer patients.
The semiologic evaluation of patients is changing, as a result of scientific advances, easier and rapid access to information, the incorporation of ICT (information and communication technologies) etc. Profound changes are expected, namely in incorporating new technologies to improve patient's evaluation.
Medicine is also called to give better support to cancer patients, which disease is not active but may evolve in the future. Cancer is more and more regarded as a chronic ailment, as the acute life-threatening conditions are fortunately becoming less and less frequent. In these cases, medicine is requested to provide ways of improving longevity with quality of life. Physical activity may play an important role in achieving such a goal. The investigators think that possibly the same kind of approach, i.e. considering physical activity, although to a different extent, should also be considered in the case of some patients with active disease. Human relationships play a very important role in supporting the patients' wellness, in impacting their quality of life, and in ensuring that the patients have the most adequate treatment, taking into account their true health conditions.
This change of paradigm in Medicine is very important in areas as Oncology. Clinicians need new tools to give the best treatment to patients. These new tools will certainly soon incorporate new technologies that will call for different patterns of patients' validation.
The question to be answered is if whether or not the introduction of new variables for the assessment of disease progression/quality of life of breast cancer patients and survivors will help improve medical reasoning of the general condition of the patient.
As future goals, subsequently to the present observational study, the investigators look forward to provide answers to:
- what kind of physical and cognitive evaluation should be offered to Breast Cancer Patients?
- How can existing knowledge on physical motility be incorporated in the clinical practice? Namely in physical, and cognitive evaluation? (and finally assessing if such evaluation has practical impact) Moreover, the extended data set, expected to be obtained in the current study, is likely to be useful in developing strategies to motivate patients to follow an active lifestyle and balanced diet, as well as in helping adapt interventions that aim at improving survival rates and the quality of life.
The relevant observations, summarized in this study, are expected to positively act on semiology evaluation of the breast cancer patients on daily medical practice, through an improved algorithm. Such algorithm should be suitable for the clinical practice and compatible with artificial intelligence tools.
- Conditions
- Breast Cancer Female
- Being tested
- clinical and physical assessment
- Keywords
- Breast cancer, Physical exercise and Breast Cancer, Cognitive status and Breast Cancer, Physical activity and quality of life of cancer patients, New tools for evaluating breast Cancer patients
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical and physical assessmentDiagnostic test
information will be collected on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer new diagnosis | group will include volunteer women, diagnosed with breast cancer, in any stage, aged 18y or more; at least 100 patients will be recruited in medical oncology appointments; all subjects should be periodically submitted to non-invasive evaluation tests - that is, clinical test/clinical and physical assessment to collect information on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life Receives: Diagnostic Test: clinical and physical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global medical assessment
during the first medical appointment general health status and cancer staging will be noted for each participant; participants will be asked about their lifestyle, namely to register those with a sedentary lifestyle vs those enrolled in any regular physical activity
Measured: 1st month at enrolment
Assessment of changes in the cardiac function/fitness status of the subjects
The modified Bruce Protocol is a cardiac stress test that includes 2 warmup stages, each lasting 3 minutes and aims at evaluate the cardiac function will be collected, assessed and registered according to current clinical practice
Measured: 1st month at enrolment, 6 and 12 months after enrolment
Secondary outcomes (3)
screening sleep disorders and assessing changes in sleeping patterns
A validated questionnaire to assist the screening of sleep disorders will be periodically applied; such questionnaire consists in 16 questions graded from 1=never to 5=always, with an interpretation guide to track the diagnostic domains: insomnia, psychiatric disorders, circadian rhythm disorder, movement disorders, and parasomnias
Measured: 1st month at enrolment, 6 and 12 months after enrolment
Assessment of changes in bone's density
Bone Densitometry - Bone densitometry (or DEXA) uses a very small dose of radiation to measure bone density and bone loss. The test can help determine any advancement of osteoporosis.
Measured: 1st month at enrolment, 6 and 12 months after enrolment
Assessment of changes in the cognitive function
Mini-Mental State Examination (MMSE) or Folstein test is a 30-point questionnaire that allows the examination of such functions as registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation
Measured: 1st month at enrolment, 6 and 12 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start1 Jun 2019 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Lisboa Ocidental
- Sponsor type
- Other government
- Collaborators
- University of Lisbon
- Responsible party
- Principal investigator, Vasco Fonseca, Centro Hospitalar Lisboa Ocidental
- Investigators
- Vasco Fonseca, Principal investigator, Hospital S Francisco Xavier - Ocidental Lisbon Hospital Center, Lisbon, PortugalPedro Sarmento, PhD, Study chair, Faculty of Human Motricity - University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831308
- Sponsor's protocol ID
- CentroHLO_EFBreastCancer
- Acronym
- EFBCancer
- Status last verified
- Feb 2019
- First submitted
- 15 Nov 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating, Following, and Supporting Breast Cancer Patients in a Better Way
- ClinicalTrials.gov ID
- NCT03831308
- Acronym / sponsor ID
- EFBCancer / CentroHLO_EFBreastCancer
- Conditions
- Breast Cancer Female
- Keywords
- Breast cancer, Physical exercise and Breast Cancer, Cognitive status and Breast Cancer, Physical activity and quality of life of cancer patients, New tools for evaluating breast Cancer patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centro Hospitalar Lisboa OcidentalOther government
- Collaborators
- University of Lisbon
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Feb 2019 (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.
The current observational study aims at analysing current semiology on breast cancer patients aiming at noting indicators and signs with significant relationship with the disease outcomes.
To reach the primary objective, of identifying most prominent indicators and signs, a study group of at least 100 female patients with breast cancer diagnosis will be recruited to participate voluntarily. The study group will include at least 20 patients with metastatic cancer and 30 patients with indication to adjuvant chemotherapy. Their physical activity habits and lifestyle will be noted. The observational study will consist in the periodic registration of the overall physical and psychological condition. The variables and tests below will be measured and registered, periodically:
- periodical assessment of the quality of life
- periodical assessment of the fitness status of the subjects
- assessment of changes in bone density/progression of osteoporosis
- assessment of changes in cognitive function
- assessment of sleep disorders
The collected results will be statistically analysed, in order to:
- Identify variables that are statistically significantly different from expected values
- quantify statistically significant differences, whenever possible
The results will be used to better describe the breast cancer population
Detailed description
Breast Cancer treatment is expected to have the best outcome when adapted to the patients' health, and physical condition. The investigators aim at contributing to produce an improved algorithm to evaluate breast cancer patients.
The semiologic evaluation of patients is changing, as a result of scientific advances, easier and rapid access to information, the incorporation of ICT (information and communication technologies) etc. Profound changes are expected, namely in incorporating new technologies to improve patient's evaluation.
Medicine is also called to give better support to cancer patients, which disease is not active but may evolve in the future. Cancer is more and more regarded as a chronic ailment, as the acute life-threatening conditions are fortunately becoming less and less frequent. In these cases, medicine is requested to provide ways of improving longevity with quality of life. Physical activity may play an important role in achieving such a goal. The investigators think that possibly the same kind of approach, i.e. considering physical activity, although to a different extent, should also be considered in the case of some patients with active disease. Human relationships play a very important role in supporting the patients' wellness, in impacting their quality of life, and in ensuring that the patients have the most adequate treatment, taking into account their true health conditions.
This change of paradigm in Medicine is very important in areas as Oncology. Clinicians need new tools to give the best treatment to patients. These new tools will certainly soon incorporate new technologies that will call for different patterns of patients' validation.
The question to be answered is if whether or not the introduction of new variables for the assessment of disease progression/quality of life of breast cancer patients and survivors will help improve medical reasoning of the general condition of the patient.
As future goals, subsequently to the present observational study, the investigators look forward to provide answers to:
- what kind of physical and cognitive evaluation should be offered to Breast Cancer Patients?
- How can existing knowledge on physical motility be incorporated in the clinical practice? Namely in physical, and cognitive evaluation? (and finally assessing if such evaluation has practical impact) Moreover, the extended data set, expected to be obtained in the current study, is likely to be useful in developing strategies to motivate patients to follow an active lifestyle and balanced diet, as well as in helping adapt interventions that aim at improving survival rates and the quality of life.
The relevant observations, summarized in this study, are expected to positively act on semiology evaluation of the breast cancer patients on daily medical practice, through an improved algorithm. Such algorithm should be suitable for the clinical practice and compatible with artificial intelligence tools.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer new diagnosis | – | Diagnostic Test: clinical and physical assessmentgroup will include volunteer women, diagnosed with breast cancer, in any stage, aged 18y or more; at least 100 patients will be recruited in medical oncology appointments; all subjects should be periodically submitted to non-invasive evaluation tests - that is, clinical test/clinical and physical assessment to collect information on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with breast cancer
Key inclusion criteria (3 listed)
- women
- age > 18y
- diagnosed with breast cancer
Key exclusion criteria (2 listed)
- men
- informed consent
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 |
|---|---|---|
| clinical and physical assessmentinformation will be collected on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life | Diagnostic test | Breast cancer new diagnosis |
Primary outcome
Global medical assessment
Time frame: 1st month at enrolment
during the first medical appointment general health status and cancer staging will be noted for each participant; participants will be asked about their lifestyle, namely to register those with a sedentary lifestyle vs those enrolled in any regular physical activity
Assessment of changes in the cardiac function/fitness status of the subjects
Time frame: 1st month at enrolment, 6 and 12 months after enrolment
The modified Bruce Protocol is a cardiac stress test that includes 2 warmup stages, each lasting 3 minutes and aims at evaluate the cardiac function will be collected, assessed and registered according to current clinical practice
3 secondary outcomes
screening sleep disorders and assessing changes in sleeping patterns
Time frame: 1st month at enrolment, 6 and 12 months after enrolment
Assessment of changes in bone's density
Time frame: 1st month at enrolment, 6 and 12 months after enrolment
Assessment of changes in the cognitive function
Time frame: 1st month at enrolment, 6 and 12 months after enrolment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Vasco Fonseca principal investigator
Hospital S Francisco Xavier - Ocidental Lisbon Hospital Center, Lisbon, Portugal
Pedro Sarmento, PhD study chair
Faculty of Human Motricity - University of Lisbon
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Centro Hospitalar Lisboa Ocidental.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasco Fonseca, Dr ((+351) 210431000 ext. 1703, medicinavf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global medical assessment (time frame: 1st month at enrolment). The study lists 2 primary outcomes in all. 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 5 Feb 2019; AzTrials last refreshed its copy on 7 Nov 2026.