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临床试验/NCT03831308
NCT03831308Unknown不适用

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

Centro Hospitalar Lisboa Ocidental0 个研究点目标入组 200 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
主要终点
Global medical assessment

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age > 18y
  • diagnosed with breast cancer

排除标准

  • informed consent

结局指标

主要结局

Global medical assessment

时间窗: 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

时间窗: 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

次要结局

  • screening sleep disorders and assessing changes in sleeping patterns(1st month at enrolment, 6 and 12 months after enrolment)
  • Assessment of changes in bone's density(1st month at enrolment, 6 and 12 months after enrolment)
  • Assessment of changes in the cognitive function(1st month at enrolment, 6 and 12 months after enrolment)

研究者

发起方
Centro Hospitalar Lisboa Ocidental
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Vasco Fonseca

Dr

Centro Hospitalar Lisboa Ocidental

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