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/NCT05990946</url>
    </required_header>
    <id_info>
      <org_study_id>K2022-285</org_study_id>
      <nct_id>NCT05990946</nct_id>
    </id_info>
    <brief_title>Smartphone-based Remote Symptom Monitoring to Improve Postoperative Rehabilitation Exercise Adherence After Video-assisted Thoracic Surgery (VATS) for Lung Cancer</brief_title>
    <official_title>A Prospective, Randomized, Controlled Study to Evaluate the Impact of Remote Symptom Management Via Smartphone App Based on Electronic Patient-Reported Outcomes on Rehabilitation Exercise Adherence After Minimally Invasive Surgery in Lung Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongshan People's Hospital, Guangdong, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongshan People's Hospital, Guangdong, China</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>
        Brief Summary: This randomized controlled trial aims to evaluate whether active remote&#xD;
        symptom monitoring and management via a smartphone app utilizing electronic patient-reported&#xD;
        outcomes (ePRO) can improve adherence to prescribed outpatient pulmonary rehabilitation&#xD;
        exercises among postsurgical lung cancer patients. Eligible patients will use the app for&#xD;
        perioperative care and be randomized to an intervention group receiving ePRO-based symptom&#xD;
        monitoring with clinician feedback or a control group receiving ePRO without feedback. The&#xD;
        primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. If&#xD;
        proven effective, the app-enabled remote rehabilitation model can be scaled up to enhance&#xD;
        recovery for more postoperative patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adherence to postoperative pulmonary rehabilitation exercises is crucial but challenging to&#xD;
        address in lung cancer patients after hospital discharge. Pain, fatigue, cough and other&#xD;
        symptoms may hinder adherence. This study will enroll 224 patients undergoing Video-assisted&#xD;
        thoracic surgery (VATS) for lung Cancer. All patients will use a smartphone app for&#xD;
        perioperative care and periodic PRO measurement. Before discharge, patients will be&#xD;
        randomized 1:1 to an intervention group or control group. The intervention group will&#xD;
        complete ePRO symptom severity scores on the PSA-Lung Scale questionnaire on discharge and&#xD;
        post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored&#xD;
        ≥4, prompting remote clinician feedback and guidance. The control group will complete ePRO&#xD;
        without clinician alerts. The primary outcome is rehabilitation exercise adherence rate over&#xD;
        1 month after discharge. Secondary outcomes include postoperative complications, hospital&#xD;
        readmissions, symptom changes, exercise participation rate, and patient satisfaction. If&#xD;
        proven effective, this innovative rehabilitation model can be scaled up to enhance recovery&#xD;
        for more postoperative patients.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">March 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Rehabilitation exercise adherence rate over 1 month after discharge</measure>
      <time_frame>From the day of discharge to 30 days after discharge</time_frame>
      <description>Rehabilitation exercise adherence rate over 1 month after discharge, defined as the proportion of patients completing the prescribed outpatient exercise regimen.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Post-discharge pulmonary complication rate</measure>
      <time_frame>From the day of discharge to 30 days after discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>30-day hospital readmission rate</measure>
      <time_frame>From the day of discharge to 30 days after discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in symptom severity scores from discharge to 30 days</measure>
      <time_frame>From the day of discharge to 30 days after discharge</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction scores</measure>
      <time_frame>From the day of discharge to 30 days after discharge</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">224</enrollment>
    <condition>Lung Neoplasms, Non-Small Cell Lung Cancer</condition>
    <condition>Postoperative Complications</condition>
    <condition>Patient Reported Outcome Measures</condition>
    <condition>Telerehabilitation</condition>
    <condition>Exercise Therapy</condition>
    <arm_group>
      <arm_group_label>Intervention Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to the intervention group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants randomized to the control group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28, without clinician alerts.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>ePRO based Remote Symptom Management</intervention_name>
      <description>Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management.</description>
      <arm_group_label>Intervention Group</arm_group_label>
      <other_name>Symptom Management</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18-75 years old&#xD;
  &#xD;
            -  Undergoing minimally invasive lung cancer resection&#xD;
  &#xD;
            -  Able to use smartphones and complete electronic questionnaires&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ECOG score &gt; 1&#xD;
  &#xD;
            -  Received neoadjuvant therapy&#xD;
  &#xD;
            -  Previous lung resection surgery&#xD;
  &#xD;
            -  Unable to exercise due to physical limitations&#xD;
  &#xD;
            -  Continuous systemic corticosteroid use within 1 month before enrollment&#xD;
  &#xD;
            -  Unresolved toxicity above Grade 1 from previous treatments&#xD;
  &#xD;
            -  Significant comorbidities or medical history&#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>Xiaojuan Yang</last_name>
      <phone>+86 0760-88823566</phone>
      <email>1002381745@qq.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>No.2 Sunwen East Rd.</name>
        <address>
          <city>Zhongshan</city>
          <state>Guangdong</state>
          <zip>528403</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xiaojuan Yang</last_name>
        <phone>+86 0760-88823566</phone>
        <email>1002381745@qq.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongshan People's Hospital, Guangdong, China</investigator_affiliation>
      <investigator_full_name>Xiaojuan Yang</investigator_full_name>
      <investigator_title>Nurse Practitioner</investigator_title>
    </responsible_party>
    <keyword>Exercise Adherence</keyword>
    <keyword>ePRO</keyword>
    <keyword>Remote Monitoring</keyword>
    <keyword>Postoperative Rehabilitation</keyword>
    <keyword>Symptom Management</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Postoperative Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Not available. The individual participant data collected in this study will not be shared with external researchers.</ipd_description>
    </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/NCT05990946
  org study id: K2022-285
  nct id: NCT05990946
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Brief Summary: This randomized controlled trial aims to evaluate whether active remote
        symptom monitoring and management via a smartphone app utilizing electronic patient-reported
        outcomes (ePRO) can improve adherence to prescribed outpatient pulmonary rehabilitation
        exercises among postsurgical lung cancer patients. Eligible patients will use the app for
        perioperative care and be randomized to an intervention group receiving ePRO-based symptom
        monitoring with clinician feedback or a control group receiving ePRO without feedback. The
        primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. If
        proven effective, the app-enabled remote rehabilitation model can be scaled up to enhance
        recovery for more postoperative patients.
  Adherence to postoperative pulmonary rehabilitation exercises is crucial but challenging to
        address in lung cancer patients after hospital discharge. Pain, fatigue, cough and other
        symptoms may hinder adherence. This study will enroll 224 patients undergoing Video-assisted
        thoracic surgery (VATS) for lung Cancer. All patients will use a smartphone app for
        perioperative care and periodic PRO measurement. Before discharge, patients will be
        randomized 1:1 to an intervention group or control group. The intervention group will
        complete ePRO symptom severity scores on the PSA-Lung Scale questionnaire on discharge and
        post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored
        ≥4, prompting remote clinician feedback and guidance. The control group will complete ePRO
        without clinician alerts. The primary outcome is rehabilitation exercise adherence rate over
        1 month after discharge. Secondary outcomes include postoperative complications, hospital
        readmissions, symptom changes, exercise participation rate, and patient satisfaction. If
        proven effective, this innovative rehabilitation model can be scaled up to enhance recovery
        for more postoperative patients.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Rehabilitation exercise adherence rate over 1 month after discharge
  time frame: From the day of discharge to 30 days after discharge
  description: Rehabilitation exercise adherence rate over 1 month after discharge, defined as the proportion of patients completing the prescribed outpatient exercise regimen.
  measure: Post-discharge pulmonary complication rate
  time frame: From the day of discharge to 30 days after discharge
  measure: 30-day hospital readmission rate
  time frame: From the day of discharge to 30 days after discharge
  measure: Changes in symptom severity scores from discharge to 30 days
  time frame: From the day of discharge to 30 days after discharge
  measure: Patient satisfaction scores
  time frame: From the day of discharge to 30 days after discharge
  arm group label: Intervention Group
  arm group type: Experimental
  description: Participants randomized to the intervention group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28. Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management.
  arm group label: Control Group
  arm group type: No Intervention
  description: Participants randomized to the control group will complete ePRO symptom severity scores on the PSA-Lung questionnaire via the smartphone app on discharge and post-discharge days 3, 7, 14, 21, 28, without clinician alerts.
  intervention type: Procedure
  intervention name: ePRO based Remote Symptom Management
  description: Alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance on symptom management.
  arm group label: Intervention Group
  other name: Symptom Management
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xiaojuan Yang
  phone: +86 0760-88823566
  email: 1002381745@qq.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhongshan People's Hospital, Guangdong, China
  investigator full name: Xiaojuan Yang
  investigator title: Nurse Practitioner
  mesh term: Lung Neoplasms
  mesh term: Postoperative Complications
  sharing ipd: No
  ipd description: Not available. The individual participant data collected in this study will not be shared with external researchers.