xml: <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/NCT06036173</url>
    </required_header>
    <id_info>
      <org_study_id>2023/09.06</org_study_id>
      <nct_id>NCT06036173</nct_id>
    </id_info>
    <brief_title>Body Awareness and Functionality in Lymphedema</brief_title>
    <official_title>Effects of Lymphedema After Breast Cancer Treatment on Body Awareness and Upper Extremity Functionality</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Selcuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Selcuk University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To determine whether body awareness and upper extremity functionality are affected in&#xD;
        patients with or without lymphedema development after breast cancer surgery in comparison&#xD;
        with individuals without a history of cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 16, 2023</start_date>
    <completion_date type="Anticipated">October 27, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Body Awareness Questionnaire</measure>
      <time_frame>17 minutes</time_frame>
      <description>This instrument consists of a total of 18 items evaluated based on a scale of 1 (not at all true of me) to 7 (very true of me). The total score is obtained by adding the scores of each item. A higher total score indicates better body awareness</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire</measure>
      <time_frame>11 minutes</time_frame>
      <description>Each of the 11 items in this instrument is scored from 1 to 5. The responses given to all items are summed up, and the total score is obtained with a special formula. A high total score indicates a high level of functional limitation</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">102</enrollment>
    <condition>Lymphedema of Upper Limb</condition>
    <arm_group>
      <arm_group_label>developed lymphedema after breast cancer surgery</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>did not develop lymphedema after breast cancer surgery</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>without a history of any cancer surgery</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>diagnosis of lymphedema</intervention_name>
      <description>being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association</description>
      <arm_group_label>developed lymphedema after breast cancer surgery</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>breast cancer surgery</intervention_name>
      <description>be diagnosed and undergo surgery</description>
      <arm_group_label>developed lymphedema after breast cancer surgery</arm_group_label>
      <arm_group_label>did not develop lymphedema after breast cancer surgery</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          being a woman and having had breast cancer surgery&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          first group:&#xD;
  &#xD;
            -  being female,&#xD;
  &#xD;
            -  being aged 18-65 years,&#xD;
  &#xD;
            -  having undergone unilateral breast cancer surgery,&#xD;
  &#xD;
            -  being diagnosed with secondary lymphedema in the upper extremity according to the&#xD;
               International Lymphedema Association&#xD;
  &#xD;
            -  not having any orthopedic disease that would prevent walking, and volunteering to&#xD;
               participate in the study.&#xD;
  &#xD;
          second group:The inclusion criteria for the breast cancer surgery group&#xD;
  &#xD;
            -  without lymphedema were being female,&#xD;
  &#xD;
            -  being aged 18-65 years,&#xD;
  &#xD;
            -  having undergone unilateral breast cancer surgery, and volunteering to participate in&#xD;
               the study.&#xD;
  &#xD;
          Lastly, the inclusion criteria for the control group were:&#xD;
  &#xD;
            -  being female,&#xD;
  &#xD;
            -  being aged 18-65 years,&#xD;
  &#xD;
            -  having no history of cancer surgery, and volunteering to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria: for all groups&#xD;
  &#xD;
            -  not being willing to participate in the study;&#xD;
  &#xD;
            -  the presence of metastases, neurological, or orthopedic disorders;&#xD;
  &#xD;
            -  postural deformities, such as scoliosis and kyphosis;&#xD;
  &#xD;
            -  mental and cognitive disorders; or communication/cooperation problems&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Emine Cihan, PhD</last_name>
      <phone>5548928407</phone>
      <phone_ext>+90</phone_ext>
      <email>pteminecihan@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cansu Sahbaz Pirincci, PhD</last_name>
      <phone>5300385085</phone>
      <phone_ext>+90</phone_ext>
      <email>cansusahbaz@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Selcuk University</name>
        <address>
          <city>Konya</city>
          <state>Selcuklu</state>
          <zip>42130</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Emine Cihan, PhD</last_name>
        <phone>5548928407</phone>
        <phone_ext>+90</phone_ext>
        <email>pteminecihan@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>September 6, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Selcuk University</investigator_affiliation>
      <investigator_full_name>Emine Cihan</investigator_full_name>
      <investigator_title>Assist. Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphedema</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036173
  org study id: 2023/09.06
  nct id: NCT06036173
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To determine whether body awareness and upper extremity functionality are affected in
        patients with or without lymphedema development after breast cancer surgery in comparison
        with individuals without a history of cancer.
  observational model: Other
  time perspective: Prospective
  measure: Body Awareness Questionnaire
  time frame: 17 minutes
  description: This instrument consists of a total of 18 items evaluated based on a scale of 1 (not at all true of me) to 7 (very true of me). The total score is obtained by adding the scores of each item. A higher total score indicates better body awareness
  measure: Quick-Disabilities of the Arm, Shoulder, and Hand questionnaire
  time frame: 11 minutes
  description: Each of the 11 items in this instrument is scored from 1 to 5. The responses given to all items are summed up, and the total score is obtained with a special formula. A high total score indicates a high level of functional limitation
  arm group label: developed lymphedema after breast cancer surgery
  arm group label: did not develop lymphedema after breast cancer surgery
  arm group label: without a history of any cancer surgery
  intervention type: Other
  intervention name: diagnosis of lymphedema
  description: being diagnosed with secondary lymphedema in the upper extremity according to the International Lymphedema Association
  arm group label: developed lymphedema after breast cancer surgery
  intervention type: Other
  intervention name: breast cancer surgery
  description: be diagnosed and undergo surgery
  arm group label: developed lymphedema after breast cancer surgery
  arm group label: did not develop lymphedema after breast cancer surgery
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 70 Years
  last name: Emine Cihan, PhD
  phone: 5548928407
  phone ext: +90
  email: pteminecihan@gmail.com
  last name: Cansu Sahbaz Pirincci, PhD
  phone: 5300385085
  phone ext: +90
  email: cansusahbaz@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Selcuk University
  investigator full name: Emine Cihan
  investigator title: Assist. Prof.
  mesh term: Lymphedema