An observational study in Breast Cancer Female, sponsored by Centro Hospitalar Lisboa Ocidental. Status unknown. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-05.
Sponsored by Centro Hospitalar Lisboa Ocidental · Observational
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:
The collected results will be statistically analysed, in order to:
The results will be used to better describe the breast cancer population
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:
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 200 is close to the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centro Hospitalar Lisboa Ocidental is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
women with breast cancer
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Diagnostic Test: clinical and physical assessment
information will be collected on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life
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
Time frame: 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
Time frame: 1st month at enrolment, 6 and 12 months after enrolment
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
Time frame: 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.
Time frame: 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
Time frame: 1st month at enrolment, 6 and 12 months after enrolment
No study locations are listed for this record.
Plan to share: Undecided — undecided
No publications or documents are linked to this record.
Start is estimated for Jun 2019; primary completion for Jun 2020, 12 months later.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 12 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Centro Hospitalar Lisboa Ocidental