<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03831308</url>
  </required_header>
  <id_info>
    <org_study_id>CentroHLO_EFBreastCancer</org_study_id>
    <nct_id>NCT03831308</nct_id>
  </id_info>
  <brief_title>Evaluating and Following Breast Cancer Patients in a Better Way</brief_title>
  <acronym>EFBCancer</acronym>
  <official_title>Evaluating, Following, and Supporting Breast Cancer Patients in a Better Way</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Hospitalar Lisboa Ocidental</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Lisbon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centro Hospitalar Lisboa Ocidental</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current observational study aims at analysing current semiology on breast cancer patients&#xD;
      aiming at noting indicators and signs with significant relationship with the disease&#xD;
      outcomes.&#xD;
&#xD;
      To reach the primary objective, of identifying most prominent indicators and signs, a study&#xD;
      group of at least 100 female patients with breast cancer diagnosis will be recruited to&#xD;
      participate voluntarily. The study group will include at least 20 patients with metastatic&#xD;
      cancer and 30 patients with indication to adjuvant chemotherapy. Their physical activity&#xD;
      habits and lifestyle will be noted. The observational study will consist in the periodic&#xD;
      registration of the overall physical and psychological condition. The variables and tests&#xD;
      below will be measured and registered, periodically:&#xD;
&#xD;
        -  periodical assessment of the quality of life&#xD;
&#xD;
        -  periodical assessment of the fitness status of the subjects&#xD;
&#xD;
        -  assessment of changes in bone density/progression of osteoporosis&#xD;
&#xD;
        -  assessment of changes in cognitive function&#xD;
&#xD;
        -  assessment of sleep disorders&#xD;
&#xD;
      The collected results will be statistically analysed, in order to:&#xD;
&#xD;
        -  Identify variables that are statistically significantly different from expected values&#xD;
&#xD;
        -  quantify statistically significant differences, whenever possible&#xD;
&#xD;
      The results will be used to better describe the breast cancer population&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast Cancer treatment is expected to have the best outcome when adapted to the patients'&#xD;
      health, and physical condition. The investigators aim at contributing to produce an improved&#xD;
      algorithm to evaluate breast cancer patients.&#xD;
&#xD;
      The semiologic evaluation of patients is changing, as a result of scientific advances, easier&#xD;
      and rapid access to information, the incorporation of ICT (information and communication&#xD;
      technologies) etc. Profound changes are expected, namely in incorporating new technologies to&#xD;
      improve patient's evaluation.&#xD;
&#xD;
      Medicine is also called to give better support to cancer patients, which disease is not&#xD;
      active but may evolve in the future. Cancer is more and more regarded as a chronic ailment,&#xD;
      as the acute life-threatening conditions are fortunately becoming less and less frequent. In&#xD;
      these cases, medicine is requested to provide ways of improving longevity with quality of&#xD;
      life. Physical activity may play an important role in achieving such a goal. The&#xD;
      investigators think that possibly the same kind of approach, i.e. considering physical&#xD;
      activity, although to a different extent, should also be considered in the case of some&#xD;
      patients with active disease. Human relationships play a very important role in supporting&#xD;
      the patients' wellness, in impacting their quality of life, and in ensuring that the patients&#xD;
      have the most adequate treatment, taking into account their true health conditions.&#xD;
&#xD;
      This change of paradigm in Medicine is very important in areas as Oncology. Clinicians need&#xD;
      new tools to give the best treatment to patients. These new tools will certainly soon&#xD;
      incorporate new technologies that will call for different patterns of patients' validation.&#xD;
&#xD;
      The question to be answered is if whether or not the introduction of new variables for the&#xD;
      assessment of disease progression/quality of life of breast cancer patients and survivors&#xD;
      will help improve medical reasoning of the general condition of the patient.&#xD;
&#xD;
      As future goals, subsequently to the present observational study, the investigators look&#xD;
      forward to provide answers to:&#xD;
&#xD;
        -  what kind of physical and cognitive evaluation should be offered to Breast Cancer&#xD;
           Patients?&#xD;
&#xD;
        -  How can existing knowledge on physical motility be incorporated in the clinical&#xD;
           practice? Namely in physical, and cognitive evaluation? (and finally assessing if such&#xD;
           evaluation has practical impact) Moreover, the extended data set, expected to be&#xD;
           obtained in the current study, is likely to be useful in developing strategies to&#xD;
           motivate patients to follow an active lifestyle and balanced diet, as well as in helping&#xD;
           adapt interventions that aim at improving survival rates and the quality of life.&#xD;
&#xD;
      The relevant observations, summarized in this study, are expected to positively act on&#xD;
      semiology evaluation of the breast cancer patients on daily medical practice, through an&#xD;
      improved algorithm. Such algorithm should be suitable for the clinical practice and&#xD;
      compatible with artificial intelligence tools.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Global medical assessment</measure>
    <time_frame>1st month at enrolment</time_frame>
    <description>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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of changes in the cardiac function/fitness status of the subjects</measure>
    <time_frame>1st month at enrolment, 6 and 12 months after enrolment</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>screening sleep disorders and assessing changes in sleeping patterns</measure>
    <time_frame>1st month at enrolment, 6 and 12 months after enrolment</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of changes in bone's density</measure>
    <time_frame>1st month at enrolment, 6 and 12 months after enrolment</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of changes in the cognitive function</measure>
    <time_frame>1st month at enrolment, 6 and 12 months after enrolment</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Breast Cancer Female</condition>
  <arm_group>
    <arm_group_label>Breast cancer new diagnosis</arm_group_label>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>clinical and physical assessment</intervention_name>
    <description>information will be collected on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life</description>
    <arm_group_label>Breast cancer new diagnosis</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women with breast cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women&#xD;
&#xD;
          -  age &gt; 18y&#xD;
&#xD;
          -  diagnosed with breast cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  men&#xD;
&#xD;
          -  informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Although it may occur, breast cancer is rare in men</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vasco Fonseca</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital S Francisco Xavier - Ocidental Lisbon Hospital Center, Lisbon, Portugal</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Pedro Sarmento, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Human Motricity - University of Lisbon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vasco Fonseca, Dr</last_name>
    <phone>(+351) 210431000</phone>
    <phone_ext>1703</phone_ext>
    <email>medicinavf@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pedro Sarmento, PhD</last_name>
    <phone>(+ 351) 965289798</phone>
    <email>pacssarmento@gmail.com</email>
  </overall_contact_backup>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 3, 2019</last_update_submitted>
  <last_update_submitted_qc>February 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Hospitalar Lisboa Ocidental</investigator_affiliation>
    <investigator_full_name>Vasco Fonseca</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Physical exercise and Breast Cancer</keyword>
  <keyword>Cognitive status and Breast Cancer</keyword>
  <keyword>Physical activity and quality of life of cancer patients</keyword>
  <keyword>New tools for evaluating breast Cancer patients</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>undecided</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03831308
org study id: CentroHLO_EFBreastCancer
nct id: NCT03831308
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Cohort
time perspective: Prospective
measure: Global medical assessment
time frame: 1st month at enrolment
description: 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
measure: Assessment of changes in the cardiac function/fitness status of the subjects
time frame: 1st month at enrolment, 6 and 12 months after enrolment
description: 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
measure: screening sleep disorders and assessing changes in sleeping patterns
time frame: 1st month at enrolment, 6 and 12 months after enrolment
description: 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
measure: Assessment of changes in bone's density
time frame: 1st month at enrolment, 6 and 12 months after enrolment
description: 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.
measure: Assessment of changes in the cognitive function
time frame: 1st month at enrolment, 6 and 12 months after enrolment
description: 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
arm group label: Breast cancer new diagnosis
description: 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
intervention type: Diagnostic Test
intervention name: clinical and physical assessment
description: information will be collected on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life
arm group label: Breast cancer new diagnosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Although it may occur, breast cancer is rare in men
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vasco Fonseca
role: Principal Investigator
affiliation: Hospital S Francisco Xavier - Ocidental Lisbon Hospital Center, Lisbon, Portugal
last name: Pedro Sarmento, PhD
role: Study Chair
affiliation: Faculty of Human Motricity - University of Lisbon
last name: Vasco Fonseca, Dr
phone: (+351) 210431000
phone ext: 1703
email: medicinavf@yahoo.com
last name: Pedro Sarmento, PhD
phone: (+ 351) 965289798
email: pacssarmento@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Centro Hospitalar Lisboa Ocidental
investigator full name: Vasco Fonseca
investigator title: Dr
mesh term: Breast Neoplasms
sharing ipd: Undecided
ipd description: undecided