Clinical trial NCT03831308: Evaluating and Following Breast Cancer Patients in a Better Way
Official title: Evaluating, Following, and Supporting Breast Cancer Patients in a Better Way
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Centro Hospitalar Lisboa Ocidental
Sponsor class: OTHER_GOV
Collaborators: name: University of Lisbon
First posted: 2019-02-05
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with breast cancer

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* women
* age \> 18y
* diagnosed with breast cancer

Exclusion Criteria:

* men
* informed consent

Primary outcomes:
measure: Global medical assessment
timeFrame: 1st month at enrolment
measure: Assessment of changes in the cardiac function/fitness status of the subjects
timeFrame: 1st month at enrolment, 6 and 12 months after enrolment
Secondary outcomes:
measure: screening sleep disorders and assessing changes in sleeping patterns
timeFrame: 1st month at enrolment, 6 and 12 months after enrolment
measure: Assessment of changes in bone's density
timeFrame: 1st month at enrolment, 6 and 12 months after enrolment
measure: Assessment of changes in the cognitive function
timeFrame: 1st month at enrolment, 6 and 12 months after enrolment
Other outcomes:
Locations:
Study officials:
affiliation: Hospital S Francisco Xavier - Ocidental Lisbon Hospital Center, Lisbon, Portugal
name: Vasco Fonseca
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Human Motricity - University of Lisbon
name: Pedro Sarmento, PhD
role: STUDY_CHAIR
References: