<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/NCT03300349</url>
  </required_header>
  <id_info>
    <org_study_id>InveCuidRh001</org_study_id>
    <nct_id>NCT03300349</nct_id>
  </id_info>
  <brief_title>Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.</brief_title>
  <official_title>Interhospital Variability in Programmes to Prevent Axillary Lymphadenectomy Sequels in Breast Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Violeta Pajero Otero</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario 12 de Octubre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Castilla-La Mancha</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Puerta de Hierro University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Complejo Hospitalario Universitario de Cartagena</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario 12 de Octubre</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>
      This study aims to determine the effectiveness of the different programmes of four Spanish&#xD;
      hospitals about prevention of axillary lymphadenectomy sequels in breast cancer patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to describe the different programs for the prevention of sequels of axillary&#xD;
      lymphadenectomy in patients with breast cancer in four Spanish hospitals, to determine the&#xD;
      degree of compliance of these programs and to register the frecuency of lymphedema and&#xD;
      limitation of mobility of the upper limb in breast cancer patients undergoing axillary&#xD;
      lymphadenectomy between 2014 and 2016 in the four hospitals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>breast cancer-related lymphedema</measure>
    <time_frame>The agreed date with the participant for the evaluation (second half of 2017)</time_frame>
    <description>Truncated cone formula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>functional shoulder limitation</measure>
    <time_frame>The agreed date with the participant for the evaluation (second half of 2017)</time_frame>
    <description>Shoulder Pain and Disability Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms associated with breast cancer-related lymphedema</measure>
    <time_frame>The agreed date with the participant for the evaluation (second half of 2017)</time_frame>
    <description>Visual Analogic Scale</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Degree of compliance with the prevention program</measure>
    <time_frame>The agreed date with the participant for the evaluation (second half of 2017)</time_frame>
    <description>questionnaire</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">276</enrollment>
  <condition>Breast Cancer Lymphedema</condition>
  <condition>Shoulder Injury</condition>
  <arm_group>
    <arm_group_label>axillary lymphadenectomy sequels</arm_group_label>
    <description>Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have developed breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No axillary lymphadenectomy sequels</arm_group_label>
    <description>Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have not develped breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fulfillment of a preventive programme</arm_group_label>
    <description>Patients who fulfil a preventive programme for axillary lymphadenectomy sequels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No fulfillment of a preventive programme</arm_group_label>
    <description>Patients who do not fulfil a preventive programme for axillary lymphadenectomy sequels</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fulfillment of a preventive programme</intervention_name>
    <description>Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder</description>
    <arm_group_label>No axillary lymphadenectomy sequels</arm_group_label>
    <arm_group_label>axillary lymphadenectomy sequels</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No fulfillment of a preventive programme</intervention_name>
    <description>No fulfillment of the preventive programme: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder</description>
    <arm_group_label>No axillary lymphadenectomy sequels</arm_group_label>
    <arm_group_label>axillary lymphadenectomy sequels</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women suffering from axillary lymphadenectomy due to breast cancer in four spanish&#xD;
        hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Suffering from axillary lymphadenectomy due to breast cancer treatment between 1&#xD;
             january 2014 until 31 december 2016.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lymphedema prior to surgery in any of the upper limbs or any malformation or injury&#xD;
             that prevents comparison of both upper limb volumes.&#xD;
&#xD;
          -  Cognitive impairment or intellectual disability that would prevent understanding the&#xD;
             instructions of the study, as well as the purpose of the same.&#xD;
&#xD;
          -  Serious condition.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Violeta Pajero Otero, MRes</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario 12 de Octubre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Hospitalario Universitario de Cartagena</name>
      <address>
        <city>Cartagena</city>
        <state>Murcia</state>
        <zip>30203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Castilla-La Mancha University</name>
      <address>
        <city>Toledo</city>
        <zip>45071</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>September 28, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Universitario 12 de Octubre</investigator_affiliation>
    <investigator_full_name>Violeta Pajero Otero</investigator_full_name>
    <investigator_title>Physiotherapist at the Mammary Pathology Unit</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Breast cancer-related lymphedema</keyword>
  <keyword>Shoulder injury</keyword>
  <keyword>Prevention</keyword>
  <keyword>Educational activity</keyword>
  <keyword>Physiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Lymphedema</mesh_term>
    <mesh_term>Breast Cancer Lymphedema</mesh_term>
    <mesh_term>Shoulder Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03300349
org study id: InveCuidRh001
nct id: NCT03300349
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to determine the effectiveness of the different programmes of four Spanish
      hospitals about prevention of axillary lymphadenectomy sequels in breast cancer patients.
This study aims to describe the different programs for the prevention of sequels of axillary
      lymphadenectomy in patients with breast cancer in four Spanish hospitals, to determine the
      degree of compliance of these programs and to register the frecuency of lymphedema and
      limitation of mobility of the upper limb in breast cancer patients undergoing axillary
      lymphadenectomy between 2014 and 2016 in the four hospitals.
observational model: Case-Control
time perspective: Retrospective
measure: breast cancer-related lymphedema
time frame: The agreed date with the participant for the evaluation (second half of 2017)
description: Truncated cone formula
measure: functional shoulder limitation
time frame: The agreed date with the participant for the evaluation (second half of 2017)
description: Shoulder Pain and Disability Index
measure: Symptoms associated with breast cancer-related lymphedema
time frame: The agreed date with the participant for the evaluation (second half of 2017)
description: Visual Analogic Scale
measure: Degree of compliance with the prevention program
time frame: The agreed date with the participant for the evaluation (second half of 2017)
description: questionnaire
arm group label: axillary lymphadenectomy sequels
description: Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have developed breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme
arm group label: No axillary lymphadenectomy sequels
description: Patients who have suffered from axillary lymphadenectomy due to breast cancer between 2014 and 2016 and who have not develped breast cancer-related lymphedema and/or shoulder disability who fulfill or not a preventive programme.
arm group label: Fulfillment of a preventive programme
description: Patients who fulfil a preventive programme for axillary lymphadenectomy sequels
arm group label: No fulfillment of a preventive programme
description: Patients who do not fulfil a preventive programme for axillary lymphadenectomy sequels
intervention type: Other
intervention name: Fulfillment of a preventive programme
description: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder
arm group label: No axillary lymphadenectomy sequels
arm group label: axillary lymphadenectomy sequels
intervention type: Other
intervention name: No fulfillment of a preventive programme
description: No fulfillment of the preventive programme: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder
arm group label: No axillary lymphadenectomy sequels
arm group label: axillary lymphadenectomy sequels
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Violeta Pajero Otero, MRes
role: Principal Investigator
affiliation: Hospital Universitario 12 de Octubre
facility: 
facility: 
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Universitario 12 de Octubre
investigator full name: Violeta Pajero Otero
investigator title: Physiotherapist at the Mammary Pathology Unit
mesh term: Breast Neoplasms
mesh term: Lymphedema
mesh term: Breast Cancer Lymphedema
mesh term: Shoulder Injuries
sharing ipd: No