<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/NCT03290352</url>
  </required_header>
  <id_info>
    <org_study_id>HKU_1</org_study_id>
    <nct_id>NCT03290352</nct_id>
  </id_info>
  <brief_title>Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer</brief_title>
  <official_title>Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer Who Underwent Free Flap Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Taipei Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Taipei Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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 shed light on an under-researched area by examining the prognostic associations of&#xD;
      pre-treatment QoL with overall survival and distant metastasis free survival among patients&#xD;
      with head and neck cancer who underwent free flap reconstruction. In addition, a validated&#xD;
      instrument specific to head and neck cancer, i.e. the University of Washington Quality of&#xD;
      Life Questionnaire (UW-QoL) was adopted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The importance of patient-related outcomes, especially quality of life (QoL) has been&#xD;
      recently emphasized in the field of oncology. In conjunction with traditional biomedical&#xD;
      indicators, QoL is recognized as a reliable parameter to reflect the health status of&#xD;
      patients with malignancy. A growing body of evidence even points out that QoL can produce&#xD;
      prognostic information which goes beyond biomedical indicators. In particular, since QoL may&#xD;
      decline before any possible deterioration in health can be detected by existing biomedical&#xD;
      measures, assessing pre-treatment QoL possibly helps identify the patients who are&#xD;
      susceptible to a higher risk of mortality after they receive cancer treatment, which may&#xD;
      greatly facilitate the process of clinical decision making. Despite the importance of&#xD;
      pre-treatment QoL, its prognostic associations with overall survival and distant metastasis&#xD;
      free survival still remain relatively under-explored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2010</start_date>
  <completion_date type="Actual">June 30, 2015</completion_date>
  <primary_completion_date type="Actual">June 30, 2014</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>Overall survival of head and neck cancer patients with free-flap reconstruction</measure>
    <time_frame>3 years 8 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction</measure>
    <time_frame>3 years 8 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>Oncology</condition>
  <arm_group>
    <arm_group_label>Head and neck cancer patients</arm_group_label>
    <description>Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis who received free flap reconstruction would be enrolled in this study. However, we excluded the patients with distant metastasis identified in their medical records, and those undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Patients who enrolled in the study were asked to respond to the University of Washington Quality of Life Questionnaire one week before undergoing free flap reconstruction.</description>
    <arm_group_label>Head and neck cancer patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Head and neck cancer patients undergoing free-flap reconstruction&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland&#xD;
             cancer and cervical lymph node metastasis, and&#xD;
&#xD;
          -  Received free flap reconstruction between November 2010 and June 2014 at a medical&#xD;
             university hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with distant metastasis identified in their medical records, or&#xD;
&#xD;
          -  Undergoing reconstruction other than anterolateral thigh, fibular bone and radial&#xD;
             forearm flaps&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>September 20, 2017</last_update_submitted>
  <last_update_submitted_qc>September 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Taipei Medical University</investigator_affiliation>
    <investigator_full_name>Chia-Chin Lin</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03290352
org study id: HKU_1
nct id: NCT03290352
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study shed light on an under-researched area by examining the prognostic associations of
      pre-treatment QoL with overall survival and distant metastasis free survival among patients
      with head and neck cancer who underwent free flap reconstruction. In addition, a validated
      instrument specific to head and neck cancer, i.e. the University of Washington Quality of
      Life Questionnaire (UW-QoL) was adopted.
The importance of patient-related outcomes, especially quality of life (QoL) has been
      recently emphasized in the field of oncology. In conjunction with traditional biomedical
      indicators, QoL is recognized as a reliable parameter to reflect the health status of
      patients with malignancy. A growing body of evidence even points out that QoL can produce
      prognostic information which goes beyond biomedical indicators. In particular, since QoL may
      decline before any possible deterioration in health can be detected by existing biomedical
      measures, assessing pre-treatment QoL possibly helps identify the patients who are
      susceptible to a higher risk of mortality after they receive cancer treatment, which may
      greatly facilitate the process of clinical decision making. Despite the importance of
      pre-treatment QoL, its prognostic associations with overall survival and distant metastasis
      free survival still remain relatively under-explored.
observational model: Cohort
time perspective: Prospective
measure: Overall survival of head and neck cancer patients with free-flap reconstruction
time frame: 3 years 8 months
measure: Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction
time frame: 3 years 8 months
arm group label: Head and neck cancer patients
description: Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis who received free flap reconstruction would be enrolled in this study. However, we excluded the patients with distant metastasis identified in their medical records, and those undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps.
intervention type: Other
intervention name: Questionnaire
description: Patients who enrolled in the study were asked to respond to the University of Washington Quality of Life Questionnaire one week before undergoing free flap reconstruction.
arm group label: Head and neck cancer patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Taipei Medical University
investigator full name: Chia-Chin Lin
investigator title: Professor
mesh term: Head and Neck Neoplasms
sharing ipd: Undecided