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/NCT06019455</url>
    </required_header>
    <id_info>
      <org_study_id>2023-FXY-017</org_study_id>
      <nct_id>NCT06019455</nct_id>
    </id_info>
    <brief_title>The Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.</brief_title>
    <official_title>A Prospective Observational Study on the Level of Patient Participation in Lung and Esophageal Cancer Patients Treated With Definitive Radiochemotherapy.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-sen University</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 assess the level of participation of thoracic cancer patients undergoing&#xD;
        definitive radiotherapy and chemotherapy ± immunotherapy in their medical processes and the&#xD;
        association between the level of participation and patients' side effects, quality of life,&#xD;
        and long-term survival. Additionally, this study will rate the level of participation from&#xD;
        both the patients' and medical staff's perspectives and will compare the differences in&#xD;
        ratings from these two viewpoints, as well as their impact on treatment outcomes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2022</start_date>
    <completion_date type="Anticipated">May 30, 2027</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2027</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>Incidence of &gt;=Grade 3 toxicities</measure>
      <time_frame>2 years</time_frame>
      <description>The percentage of patients who develop &gt;=Grade 3 toxicities</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>2 years</time_frame>
      <description>2-year survival rate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>2 years</time_frame>
      <description>2-year progression-free survival rate</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Lung Cancer</condition>
    <condition>Esophageal Cancer</condition>
    <arm_group>
      <arm_group_label>Observational group</arm_group_label>
      <description>Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with locally advanced non-small cell lung cancer, limited-stage small cell lung&#xD;
          cancer, or esophageal cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Locally advanced non-small cell lung cancer, limited-stage small cell lung cancer, and&#xD;
               esophageal cancer.&#xD;
  &#xD;
            2. Planned to undergo definitive chemoradiotherapy ± immunotherapy;&#xD;
  &#xD;
            3. Males or females aged 18 to 75;&#xD;
  &#xD;
            4. Able to communicate with medical staff.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with cognitive impairments.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Bo Qiu</last_name>
      <phone>+862087343031</phone>
      <email>qiubo@sysucc.org.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <zip>510060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Bo Qiu, Ph.D</last_name>
        <phone>+862087343031</phone>
        <email>qiubo@sysucc.org.cn</email>
      </contact>
      <contact_backup>
        <last_name>Hui Liu, Ph.D</last_name>
        <phone>+862087343031</phone>
        <email>liuhui@sysucc.org.cn</email>
      </contact_backup>
      <investigator>
        <last_name>Hui Liu, Ph.D</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>Hui Liu</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>Esophageal 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>
  
  
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/NCT06019455
  org study id: 2023-FXY-017
  nct id: NCT06019455
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims to assess the level of participation of thoracic cancer patients undergoing
        definitive radiotherapy and chemotherapy ± immunotherapy in their medical processes and the
        association between the level of participation and patients' side effects, quality of life,
        and long-term survival. Additionally, this study will rate the level of participation from
        both the patients' and medical staff's perspectives and will compare the differences in
        ratings from these two viewpoints, as well as their impact on treatment outcomes.
  observational model: Cohort
  time perspective: Prospective
  measure: Incidence of >=Grade 3 toxicities
  time frame: 2 years
  description: The percentage of patients who develop >=Grade 3 toxicities
  measure: Overall survival
  time frame: 2 years
  description: 2-year survival rate
  measure: Progression-free survival
  time frame: 2 years
  description: 2-year progression-free survival rate
  arm group label: Observational group
  description: Patients undergoing definitive radiochemotherapy ± immunotherapy will be assessed about the level of participation in their medical processes.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Bo Qiu
  phone: +862087343031
  email: qiubo@sysucc.org.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sun Yat-sen University
  investigator full name: Hui Liu
  investigator title: Professor
  mesh term: Esophageal Neoplasms
  sharing ipd: Undecided