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/NCT06016881</url>
    </required_header>
    <id_info>
      <org_study_id>POSLS-union01</org_study_id>
      <nct_id>NCT06016881</nct_id>
    </id_info>
    <brief_title>Postoperative Chronic Operation-related Symptoms After Minimally Invasive Lung Surgery</brief_title>
    <official_title>Prospective Observational Study of Postoperative Chronic Operation-related Symptoms and Long-term Survival Quality After Minimally Invasive Lung Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fujian Medical University Union Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fujian Medical University Union Hospital</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>
        Lung cancer has been the most commonly diagnosed cancer globally over the past few decades.&#xD;
        Histologically, adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are&#xD;
        defined as cancers with no or limited tissue infiltration. Studies have shown that patients&#xD;
        with AIS or MIA have a 100% probability of being free of recurrence within 5 years after&#xD;
        surgery and have disease-specific survival rates of 100% and 100%, respectively.&#xD;
  &#xD;
        In patients with early-stage lung cancer and benign lesions, long-term postoperative survival&#xD;
        and tumor recurrence are non-priorities. Therefore, perioperative and postoperative quality&#xD;
        of life are increasingly emphasized by patients and clinicians. However, a significant&#xD;
        proportion of patients undergoing minimally invasive lung surgery still develop chronic pain&#xD;
        and chronic cough in the postoperative period, the severity of which can lead to reduced&#xD;
        quality of life. In addition, studies of the psychological state of patients undergoing&#xD;
        surgery for pulmonary nodules are rare, and we believe this is one of the valuable factors&#xD;
        affecting quality of life. The investigators have launched the first prospective&#xD;
        observational trial to investigate the incidence of long-term chronic symptoms after&#xD;
        minimally invasive lung surgery, risk factors, treatment received and treatment efficacy,&#xD;
        duration of disease, and eventual regression, in addition to pre- and postoperative&#xD;
        psychological status and long-term postoperative quality of life in patients undergoing&#xD;
        minimally invasive lung surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lung cancer has been the most commonly diagnosed cancer globally over the past few decades.&#xD;
        With the widespread use of Low-dose computedtomograph (LDCT), more and more lung nodules are&#xD;
        being detected. With the exception of benign nodules, the vast majority of lung cancer&#xD;
        nodules are early stage lung cancers with predominantly ground glass lesions. Histologically,&#xD;
        adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are defined as&#xD;
        cancers with no or limited tissue infiltration. Studies have shown that patients with AIS or&#xD;
        MIA have a 100% probability of being free of recurrence within 5 years after surgery and have&#xD;
        disease-specific survival rates of 100% and 100%, respectively.&#xD;
  &#xD;
        In patients with early-stage lung cancer and benign lesions, long-term postoperative survival&#xD;
        and tumor recurrence are non-priorities. Therefore, perioperative and postoperative quality&#xD;
        of life are increasingly emphasized by patients and clinicians. Enhanced rapid recovery&#xD;
        management after video-assisted thoracoscopic surgery (VATS) can minimize the damage and&#xD;
        impact of surgery on patients. However, a significant proportion of patients undergoing&#xD;
        minimally invasive lung surgery still develop chronic pain and chronic cough in the&#xD;
        postoperative period, the severity of which can lead to reduced quality of life. In addition,&#xD;
        studies of the psychological state of patients undergoing surgery for pulmonary nodules are&#xD;
        rare, and we believe this is one of the valuable factors affecting quality of life. The&#xD;
        investigators have launched the first prospective observational trial to investigate the&#xD;
        incidence of long-term chronic symptoms after minimally invasive lung surgery, risk factors,&#xD;
        treatment received and treatment efficacy, duration of disease, and eventual regression, in&#xD;
        addition to pre- and postoperative psychological status and long-term postoperative quality&#xD;
        of life in patients undergoing minimally invasive lung surgery.&#xD;
  &#xD;
        The researchers included patients with stage I lung cancer and benign lesions who underwent&#xD;
        single-port thoracoscopic lung surgery. Patients' baseline levels, including usual chronic&#xD;
        pain, chronic cough, and sleep, were recorded prior to surgery, and anxiety, depression, and&#xD;
        quality of life scores were performed using the Generalized Anxiety Disorder Screener&#xD;
        (GAD-7), Beck Depression Inventory (BDI), and the European Organisation for Research and&#xD;
        Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30). For the first 3&#xD;
        days after surgery, pain and cough were assessed using the numeric pain rating scale (NRS)&#xD;
        and the visual simulation scale (VAS) score 3 times a day (every 8 hours), and sleep status&#xD;
        were recorded each day. Postoperative chronic symptoms and quality of life will be assessed&#xD;
        at postoperative weeks 1, 2, 4, 12, 26, and 52. Chronic cough will be assessed using the&#xD;
        Leicester Cough Questionnaire, chronic pain will be assessed using Brief Pain Inventory and&#xD;
        McGill Pain Questionnaire, and EORTC QLQ-C30 questionnaire, GAD-7 and BDI for continuous&#xD;
        assessment of quality of life, anxiety status and depression status, as well as to record the&#xD;
        time of onset of chronic symptoms, predisposing factors, aggravating and relieving factors,&#xD;
        the presence or absence of treatment, the effectiveness of the treatment, and time of&#xD;
        exacerbation, remission or disappearance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 18, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Change from baseline in pain scores on the Brief Pain Inventory and the McGill Pain Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative chronic cough</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Number of participants with postoperative chronic cough as assessed by the Leicester Cough Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of life after surgery</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Change from baseline in quality of life scores on the European Organisation for Research and Treatment of Cancer 30 item Quality of Life Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Anxiety status</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Number of participants with anxiety as assessed by the Generalized Anxiety Disorder Screener at postoperative weeks 1, 2, 4, 12, 26, and 52.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression status</measure>
      <time_frame>12 months after surgery</time_frame>
      <description>Number of participants with depression as assessed by the Depression Inventory at postoperative weeks 1, 2, 4, 12, 26, and 52.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">500</enrollment>
    <condition>Lung Cancer Stage I</condition>
    <condition>Quality of Life</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The patient underwent a single-port thoracoscopic lung resection and had postoperative&#xD;
          pathologic confirmation of stage I lung cancer or a benign lesion.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Aged 18 years or above;&#xD;
  &#xD;
            2. Received single-port thoracoscopic surgery;&#xD;
  &#xD;
            3. Diagnosed with stage I lung cancer or benign lesions by histologic examination;&#xD;
  &#xD;
            4. Volunteered to participate in the study and signed an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous thoracic surgery&#xD;
  &#xD;
            2. Any type of chronic pain, requiring daily use of analgetics&#xD;
  &#xD;
            3. Any type of chronic cough that requires daily medication&#xD;
  &#xD;
            4. pregnant&#xD;
  &#xD;
            5. Breast feeding&#xD;
  &#xD;
            6. contraindications to NSAID&#xD;
  &#xD;
            7. Combination of other tumors requiring chemotherapy or radiotherapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maohui Chen</last_name>
      <role>Study Chair</role>
      <affiliation>Fujian Medical University Union Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maohui Chen</last_name>
      <phone>+8618659181171</phone>
      <email>757860733@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Maohui Chen</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350100</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Maohui Chen</last_name>
        <phone>18659181171</phone>
        <email>757860733@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>lung cancer</keyword>
    <keyword>Surgery</keyword>
    <keyword>Quality of Life</keyword>
    <!-- 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/NCT06016881
  org study id: POSLS-union01
  nct id: NCT06016881
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Lung cancer has been the most commonly diagnosed cancer globally over the past few decades.
        Histologically, adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are
        defined as cancers with no or limited tissue infiltration. Studies have shown that patients
        with AIS or MIA have a 100% probability of being free of recurrence within 5 years after
        surgery and have disease-specific survival rates of 100% and 100%, respectively.
  
        In patients with early-stage lung cancer and benign lesions, long-term postoperative survival
        and tumor recurrence are non-priorities. Therefore, perioperative and postoperative quality
        of life are increasingly emphasized by patients and clinicians. However, a significant
        proportion of patients undergoing minimally invasive lung surgery still develop chronic pain
        and chronic cough in the postoperative period, the severity of which can lead to reduced
        quality of life. In addition, studies of the psychological state of patients undergoing
        surgery for pulmonary nodules are rare, and we believe this is one of the valuable factors
        affecting quality of life. The investigators have launched the first prospective
        observational trial to investigate the incidence of long-term chronic symptoms after
        minimally invasive lung surgery, risk factors, treatment received and treatment efficacy,
        duration of disease, and eventual regression, in addition to pre- and postoperative
        psychological status and long-term postoperative quality of life in patients undergoing
        minimally invasive lung surgery.
  Lung cancer has been the most commonly diagnosed cancer globally over the past few decades.
        With the widespread use of Low-dose computedtomograph (LDCT), more and more lung nodules are
        being detected. With the exception of benign nodules, the vast majority of lung cancer
        nodules are early stage lung cancers with predominantly ground glass lesions. Histologically,
        adenocarcinoma in situ (AIS) and minimally invasive adenocarcinoma (MIA) are defined as
        cancers with no or limited tissue infiltration. Studies have shown that patients with AIS or
        MIA have a 100% probability of being free of recurrence within 5 years after surgery and have
        disease-specific survival rates of 100% and 100%, respectively.
  
        In patients with early-stage lung cancer and benign lesions, long-term postoperative survival
        and tumor recurrence are non-priorities. Therefore, perioperative and postoperative quality
        of life are increasingly emphasized by patients and clinicians. Enhanced rapid recovery
        management after video-assisted thoracoscopic surgery (VATS) can minimize the damage and
        impact of surgery on patients. However, a significant proportion of patients undergoing
        minimally invasive lung surgery still develop chronic pain and chronic cough in the
        postoperative period, the severity of which can lead to reduced quality of life. In addition,
        studies of the psychological state of patients undergoing surgery for pulmonary nodules are
        rare, and we believe this is one of the valuable factors affecting quality of life. The
        investigators have launched the first prospective observational trial to investigate the
        incidence of long-term chronic symptoms after minimally invasive lung surgery, risk factors,
        treatment received and treatment efficacy, duration of disease, and eventual regression, in
        addition to pre- and postoperative psychological status and long-term postoperative quality
        of life in patients undergoing minimally invasive lung surgery.
  
        The researchers included patients with stage I lung cancer and benign lesions who underwent
        single-port thoracoscopic lung surgery. Patients' baseline levels, including usual chronic
        pain, chronic cough, and sleep, were recorded prior to surgery, and anxiety, depression, and
        quality of life scores were performed using the Generalized Anxiety Disorder Screener
        (GAD-7), Beck Depression Inventory (BDI), and the European Organisation for Research and
        Treatment of Cancer (EORTC) 30 item Quality of Life Questionnaire (QLQ-C30). For the first 3
        days after surgery, pain and cough were assessed using the numeric pain rating scale (NRS)
        and the visual simulation scale (VAS) score 3 times a day (every 8 hours), and sleep status
        were recorded each day. Postoperative chronic symptoms and quality of life will be assessed
        at postoperative weeks 1, 2, 4, 12, 26, and 52. Chronic cough will be assessed using the
        Leicester Cough Questionnaire, chronic pain will be assessed using Brief Pain Inventory and
        McGill Pain Questionnaire, and EORTC QLQ-C30 questionnaire, GAD-7 and BDI for continuous
        assessment of quality of life, anxiety status and depression status, as well as to record the
        time of onset of chronic symptoms, predisposing factors, aggravating and relieving factors,
        the presence or absence of treatment, the effectiveness of the treatment, and time of
        exacerbation, remission or disappearance.
  observational model: Cohort
  time perspective: Prospective
  measure: Postoperative pain
  time frame: 12 months after surgery
  description: Change from baseline in pain scores on the Brief Pain Inventory and the McGill Pain Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.
  measure: Postoperative chronic cough
  time frame: 12 months after surgery
  description: Number of participants with postoperative chronic cough as assessed by the Leicester Cough Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.
  measure: Quality of life after surgery
  time frame: 12 months after surgery
  description: Change from baseline in quality of life scores on the European Organisation for Research and Treatment of Cancer 30 item Quality of Life Questionnaire at postoperative weeks 1, 2, 4, 12, 26, and 52.
  measure: Anxiety status
  time frame: 12 months after surgery
  description: Number of participants with anxiety as assessed by the Generalized Anxiety Disorder Screener at postoperative weeks 1, 2, 4, 12, 26, and 52.
  measure: Depression status
  time frame: 12 months after surgery
  description: Number of participants with depression as assessed by the Depression Inventory at postoperative weeks 1, 2, 4, 12, 26, and 52.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Maohui Chen
  role: Study Chair
  affiliation: Fujian Medical University Union Hospital
  last name: Maohui Chen
  phone: +8618659181171
  email: 757860733@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor