Evaluating and Following Breast Cancer Patients in a Better Way

Breast Cancer Female Clinical Trial

— EFBCancer  

Official title:

Evaluating, Following, and Supporting Breast Cancer Patients in a Better Way

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03831308
• Other study ID #: CentroHLO_EFBreastCancer
• Status: Not yet recruiting
• Start date: June 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: February 2019
• Source: Centro Hospitalar Lisboa Ocidental
• Contact: Vasco Fonseca, Dr
• Phone: (+351) 210431000
• Email: medicinavf[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• women

• age > 18y

• diagnosed with breast cancer

Exclusion Criteria:

• men

• informed consent

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Ocidental	University of Lisbon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1st month at enrolment
Primary	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	1st month at enrolment, 6 and 12 months after enrolment
Secondary	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	1st month at enrolment, 6 and 12 months after enrolment
Secondary	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.	1st month at enrolment, 6 and 12 months after enrolment
Secondary	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	1st month at enrolment, 6 and 12 months after enrolment