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/NCT06033716</url>
    </required_header>
    <id_info>
      <org_study_id>2020-273-1</org_study_id>
      <nct_id>NCT06033716</nct_id>
    </id_info>
    <brief_title>Development and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors</brief_title>
    <official_title>Exploring the Developmental Changes and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors: Based on Latent Growth Modeling and Cross-lagged Modeling</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing Medical 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>
        This study will explore the dynamic interaction between mental resilience, anxiety and&#xD;
        depression in elderly patients with gastric cancer 1 year after surgery, in order to better&#xD;
        understand the role of these two factors in patients' mental health, and provide accurate&#xD;
        insights for clinical practice and targeted psychological support strategies.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Actual">October 31, 2022</completion_date>
    <primary_completion_date type="Actual">October 31, 2022</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>resilience</measure>
      <time_frame>immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)</time_frame>
      <description>The Chinese version of 10-item Connor-Davidson Resilience Scale (CD-RISC-10), translated and revised by Chinese scholars, was used in this study. Cronbach's alpha for the Chinese version was 0.855, indicating good internal consistency. It was also applied to cancer patients in China. Each of which was scored on a 5-point Likert scale, ranging from 1 to 5 points, from &quot;Never&quot; to &quot;Almost always&quot;, with higher scores representing a higher level of psychological resilience.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>anxiety</measure>
      <time_frame>immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)</time_frame>
      <description>Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used in this study to assess the anxiety and depression of elderly cancer patients, which was developed by Zigmond AS et al. The scale consists of 14 items, including anxiety and depression subscales. Each item is rated on a 4 point scale, and the scores of the anxiety and depression scales range from 0 to 21 points. The Cronbach's α coefficient of the HADS for this study was 0.85.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>depression</measure>
      <time_frame>immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)</time_frame>
      <description>Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used in this study to assess the anxiety and depression of elderly cancer patients, which was developed by Zigmond AS et al. The scale consists of 14 items, including anxiety and depression subscales. Each item is rated on a 4 point scale, and the scores of the anxiety and depression scales range from 0 to 21 points. The Cronbach's α coefficient of the HADS for this study was 0.85.</description>
    </primary_outcome>
    <enrollment type="Actual">412</enrollment>
    <condition>Resilience</condition>
    <condition>Anxiety</condition>
    <condition>Depression</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Measurement correlation variable</intervention_name>
      <description>resilience and anxiety and depression</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          select elderly gastric cancer patients who had undergone cancer surgery and were receiving&#xD;
          medical treatment at a tertiary hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosed with gastric cancer by endoscopy or pathology&#xD;
  &#xD;
            -  age ≥60 years old&#xD;
  &#xD;
            -  radical gastrectomy was proposed&#xD;
  &#xD;
            -  be able to communicate simply in writing and verbal&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  received preoperative radiotherapy or chemotherapy;&#xD;
  &#xD;
            -  combined with other sites of malignant tumors;&#xD;
  &#xD;
            -  combined with severe heart, liver, lung and renal insufficiency;&#xD;
  &#xD;
            -  recent using hormones, immunosuppressants;&#xD;
  &#xD;
            -  with physical disabilities.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Yinning Guo</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
      <investigator_full_name>Yinning Guo</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>gastric cancer</keyword>
    <keyword>resilience</keyword>
    <keyword>anxiety</keyword>
    <keyword>depression</keyword>
    <keyword>trajectory</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Depressive Disorder</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06033716
  org study id: 2020-273-1
  nct id: NCT06033716
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study will explore the dynamic interaction between mental resilience, anxiety and
        depression in elderly patients with gastric cancer 1 year after surgery, in order to better
        understand the role of these two factors in patients' mental health, and provide accurate
        insights for clinical practice and targeted psychological support strategies.
  observational model: Cohort
  time perspective: Prospective
  measure: resilience
  time frame: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)
  description: The Chinese version of 10-item Connor-Davidson Resilience Scale (CD-RISC-10), translated and revised by Chinese scholars, was used in this study. Cronbach's alpha for the Chinese version was 0.855, indicating good internal consistency. It was also applied to cancer patients in China. Each of which was scored on a 5-point Likert scale, ranging from 1 to 5 points, from "Never" to "Almost always", with higher scores representing a higher level of psychological resilience.
  measure: anxiety
  time frame: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)
  description: Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used in this study to assess the anxiety and depression of elderly cancer patients, which was developed by Zigmond AS et al. The scale consists of 14 items, including anxiety and depression subscales. Each item is rated on a 4 point scale, and the scores of the anxiety and depression scales range from 0 to 21 points. The Cronbach's α coefficient of the HADS for this study was 0.85.
  measure: depression
  time frame: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)
  description: Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used in this study to assess the anxiety and depression of elderly cancer patients, which was developed by Zigmond AS et al. The scale consists of 14 items, including anxiety and depression subscales. Each item is rated on a 4 point scale, and the scores of the anxiety and depression scales range from 0 to 21 points. The Cronbach's α coefficient of the HADS for this study was 0.85.
  intervention type: Other
  intervention name: Measurement correlation variable
  description: resilience and anxiety and depression
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Nanjing Medical University
  investigator full name: Yinning Guo
  investigator title: Principal Investigator
  mesh term: Stomach Neoplasms
  mesh term: Depression
  mesh term: Depressive Disorder
  mesh term: Anxiety Disorders