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/NCT06026839</url>
    </required_header>
    <id_info>
      <org_study_id>SYSKY-2022-339-01</org_study_id>
      <nct_id>NCT06026839</nct_id>
    </id_info>
    <brief_title>Longitudinal Study on the QoL of Pediatric Patients After HSCT and Its Influencing Factors</brief_title>
    <official_title>Longitudinal Study on the Quality of Life of Pediatric Patients After Hematopoietic Stem Cell Transplantation and Its Influencing Factors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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>
        Objective: To longitudinally track the dynamic changes in the survival quality of pediatric&#xD;
        patients after hematopoietic stem cell transplantation at different time points within 1 year&#xD;
        post-transplantation, analyze the influencing factors of survival quality at each time point,&#xD;
        identify independent risk factors that can be intervened, provide reference for medical staff&#xD;
        to recognize survival quality problems early, guide the dynamic management of clinical&#xD;
        survival quality, and formulate continuation care management plans.&#xD;
  &#xD;
        Methods: This study adopted a repeated measurement study design. A total of 250 pediatric&#xD;
        patients who underwent hematopoietic stem cell transplantation in three tertiary hospitals in&#xD;
        Guangdong Province from August 2023 to December 2025 and met the research standards were&#xD;
        selected as the research subjects. The &quot;Childhood Health Assessment Questionnaire Transplant&#xD;
        Module 3.0 Chinese Version&quot; was used to evaluate the survival quality of the patients at six&#xD;
        time points: 1 week before pre-treatment (T0), the day of stem cell infusion (T1), 1 month&#xD;
        (T2), 3 months (T3), 6 months (T4), and 1 year (T5) after transplantation. Statistical&#xD;
        methods for repeated measures were used to analyze the relevant information, and mixed-effect&#xD;
        linear models were used to analyze the influencing factors of survival quality at the six&#xD;
        time points, and to identify independent risk factors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objective: longitudinal tracking hematopoietic stem cell transplantation in 1 years after&#xD;
        transplantation in different time points of the quality of life dynamic change trajectory,&#xD;
        analyze the factors of quality of each time point, looking for independent risk factors for&#xD;
        intervention, early identification of life quality for medical staff, guide the clinical&#xD;
        quality of life dynamic management and continuation of nursing management plan to provide&#xD;
        reference basis. Methods: In this study, 250 children with routine HSCT transplantation were&#xD;
        selected from August 2023 to December 2025 (T1), 1 month (T2), 3 months after&#xD;
        transplantation, 1 year after transplantation (T5). Statistical analysis of relevant&#xD;
        information was performed using repeated measures, and the influencing factors of QOL at six&#xD;
        time points were used to identify their independent risk factors.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>PedsQL™ 3.0</measure>
      <time_frame>2023.6.30-2024.12.31</time_frame>
      <description>the Chinese mandarin version of PedsQL™ 3.0 transplant module</description>
    </primary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Thalassemia Major</condition>
    <condition>Acute Leukemia</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Conventional nursing</intervention_name>
      <description>Conventional nursing</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This is a planned study on hematopoietic stem cell transplantation for children aged&#xD;
          between 0 and 18 years old who will receive a stem cell infusion. The children must be&#xD;
          conscious, have a certain level of cognitive ability and be able to express their physical&#xD;
          and psychological state accurately. If the child is under 8 years old, their caregiver&#xD;
          should have a primary school or higher education level with sufficient reading&#xD;
          comprehension and expression abilities. It is important that both the child and the legal&#xD;
          guardian are informed and consent to participate in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. children aged between 0 and 18 years old who will receive a stem cell infusion&#xD;
  &#xD;
            2. conscious, have a certain level of cognitive ability and be able to express their&#xD;
               physical and psychological state accurately&#xD;
  &#xD;
            3. If the child is under 8 years old, their caregiver should have a primary school or&#xD;
               higher education level with sufficient reading comprehension and expression abilities&#xD;
  &#xD;
            4. both the child and the legal guardian are informed and consent to participate in the&#xD;
               study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. the child has a history of mental illness&#xD;
  &#xD;
            2. the child has severe organ failure or other serious complications involving the heart,&#xD;
               brain, lungs, liver, kidneys, and other organs&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>2 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ting Zhong</last_name>
      <phone>81332009</phone>
      <email>33557423@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-sen Memorial Hospital, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510030</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Ting Zhong</last_name>
        <phone>18127880028</phone>
        <email>33557423@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>hematopoietic stem cell transplantation</keyword>
    <keyword>children</keyword>
    <keyword>quality of life</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thalassemia</mesh_term>
      <mesh_term>beta-Thalassemia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Since the study involves vulnerable populations, consent from guardians must be obtained before further data sharing can take place. This is to protect research subjects and adhere to ethical guidelines. During the process of data sharing, strict control over data usage is needed to ensure confidentiality and security of the data.</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>April 25, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT06026839/Prot_ICF_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>April 25, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT06026839/SAP_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT06026839
  org study id: SYSKY-2022-339-01
  nct id: NCT06026839
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Objective: To longitudinally track the dynamic changes in the survival quality of pediatric
        patients after hematopoietic stem cell transplantation at different time points within 1 year
        post-transplantation, analyze the influencing factors of survival quality at each time point,
        identify independent risk factors that can be intervened, provide reference for medical staff
        to recognize survival quality problems early, guide the dynamic management of clinical
        survival quality, and formulate continuation care management plans.
  
        Methods: This study adopted a repeated measurement study design. A total of 250 pediatric
        patients who underwent hematopoietic stem cell transplantation in three tertiary hospitals in
        Guangdong Province from August 2023 to December 2025 and met the research standards were
        selected as the research subjects. The "Childhood Health Assessment Questionnaire Transplant
        Module 3.0 Chinese Version" was used to evaluate the survival quality of the patients at six
        time points: 1 week before pre-treatment (T0), the day of stem cell infusion (T1), 1 month
        (T2), 3 months (T3), 6 months (T4), and 1 year (T5) after transplantation. Statistical
        methods for repeated measures were used to analyze the relevant information, and mixed-effect
        linear models were used to analyze the influencing factors of survival quality at the six
        time points, and to identify independent risk factors.
  Objective: longitudinal tracking hematopoietic stem cell transplantation in 1 years after
        transplantation in different time points of the quality of life dynamic change trajectory,
        analyze the factors of quality of each time point, looking for independent risk factors for
        intervention, early identification of life quality for medical staff, guide the clinical
        quality of life dynamic management and continuation of nursing management plan to provide
        reference basis. Methods: In this study, 250 children with routine HSCT transplantation were
        selected from August 2023 to December 2025 (T1), 1 month (T2), 3 months after
        transplantation, 1 year after transplantation (T5). Statistical analysis of relevant
        information was performed using repeated measures, and the influencing factors of QOL at six
        time points were used to identify their independent risk factors.
  observational model: Cohort
  time perspective: Prospective
  measure: PedsQL™ 3.0
  time frame: 2023.6.30-2024.12.31
  description: the Chinese mandarin version of PedsQL™ 3.0 transplant module
  intervention type: Other
  intervention name: Conventional nursing
  description: Conventional nursing
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 2 Years
  maximum age: 18 Years
  healthy volunteers: No
  last name: Ting Zhong
  phone: 81332009
  email: 33557423@163.com
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Thalassemia
  mesh term: beta-Thalassemia
  sharing ipd: Undecided
  ipd description: Since the study involves vulnerable populations, consent from guardians must be obtained before further data sharing can take place. This is to protect research subjects and adhere to ethical guidelines. During the process of data sharing, strict control over data usage is needed to ensure confidentiality and security of the data.
  provided document: 
  provided document: 