<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/NCT03290001</url>
  </required_header>
  <id_info>
    <org_study_id>anxiety and depression</org_study_id>
    <nct_id>NCT03290001</nct_id>
  </id_info>
  <brief_title>The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients</brief_title>
  <official_title>The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients: a Prospective Observational Cohort Study</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>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>
      This is a prospective, observational cohort study aimed to explore the influence of anxiety&#xD;
      and depression to long term survival in nasopharyngeal carcinoma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Radiotherapy&#xD;
      (RT) and chemotherapy are the mainstays of therapy for NPC because these tumors are&#xD;
      biologically highly radiosensitive and chemosensitive. Anxiety and depression symptoms were&#xD;
      common psychological symptoms around the time of cancer diagnosis and were often persistent&#xD;
      during cancer treatment. Psychological symptoms are associated with prolonged hospital stays,&#xD;
      lower quality of life, and worse treatment adherence among patients with cancer. Depressive&#xD;
      symptoms have been demonstrated to predict early mortality among patients with some kinds of&#xD;
      cancer. But among NPC patients, the influence of anxiety and depression symptoms to long term&#xD;
      survival have not be explored. Therefore, this prospective, observational cohort study aimed&#xD;
      to explore the influence of anxiety and depression to long term survival in NPC patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2017</start_date>
  <completion_date type="Anticipated">September 20, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 20, 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>Progress-free survival</measure>
    <time_frame>3 years</time_frame>
    <description>Progress-free survival is calculated from the date of registration to the date of the first progress at any site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anxiety related measure</measure>
    <time_frame>Baseline, completion of radiation therapy (up to 12 weeks)</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) and Hamilton Anxiety Rating Scale (HAMA) will be used during the assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress related measure</measure>
    <time_frame>Baseline, completion of radiation therapy (up to 12 weeks)</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS) and Hamilton Depression Rating Scale (HAMD) will be used during the assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival(OS)</measure>
    <time_frame>3 years</time_frame>
    <description>The OS was defined as the duration from the date of registration assignment to the date of death from any cause or censored at the date of the last follow-up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional Relapse-Free Survival(LRFS)</measure>
    <time_frame>3 years</time_frame>
    <description>The LRFS is evaluated and calculated from the date of registration until the day of first locoregional relapse or until the date of the last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant Metastasis-Free Survival (DMFS)</measure>
    <time_frame>3 years</time_frame>
    <description>The DMFS is evaluated and calculated from the date of registration until the day of first distant metastases or until the date of the last follow-up visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response (CR)</measure>
    <time_frame>completion of radiation therapy (up to 12 weeks)</time_frame>
    <description>CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight Loss</measure>
    <time_frame>Baseline, completion of radiation therapy (up to 12 weeks)</time_frame>
    <description>Weight loss was calculated as the relative percent of weight changes between weight measurement before and after the nasopharyngeal carcinoma treatment. Weight loss was calculated from the following formula:（ pro-treatment body weight - post-treatment body weight）/ pro-treatment body weight.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Nasopharyngeal Carcinoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        University hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with newly histologically confirmed non-keratinizing nasopharyngeal&#xD;
             carcinoma, including WHO II or III&#xD;
&#xD;
          -  Age between 18-70&#xD;
&#xD;
          -  Male and no pregnant female&#xD;
&#xD;
          -  Patient have signed on the informed consent, and well understood the objective and&#xD;
             procedure of this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of uncontrolled life-threatening illness&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Patient with severe medical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>HaiQiang Mai</last_name>
    <phone>8620-8734-3380</phone>
    <email>maihq@sysucc.org.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Linquan Tang</last_name>
      <phone>8620-8734-3380</phone>
      <email>tanglq@sysucc.org.cn</email>
    </contact>
    <contact_backup>
      <last_name>Liping Chen</last_name>
      <phone>8620-8734-3380</phone>
      <email>chenlp@sysucc.org.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 3, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>November 4, 2017</last_update_submitted>
  <last_update_submitted_qc>November 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Hai-Qiang Mai,MD,PhD</investigator_full_name>
    <investigator_title>Deputy Director of the Department of Nasopharyngeal Carcinoma</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03290001
org study id: anxiety and depression
nct id: NCT03290001
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a prospective, observational cohort study aimed to explore the influence of anxiety
      and depression to long term survival in nasopharyngeal carcinoma patients.
Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Radiotherapy
      (RT) and chemotherapy are the mainstays of therapy for NPC because these tumors are
      biologically highly radiosensitive and chemosensitive. Anxiety and depression symptoms were
      common psychological symptoms around the time of cancer diagnosis and were often persistent
      during cancer treatment. Psychological symptoms are associated with prolonged hospital stays,
      lower quality of life, and worse treatment adherence among patients with cancer. Depressive
      symptoms have been demonstrated to predict early mortality among patients with some kinds of
      cancer. But among NPC patients, the influence of anxiety and depression symptoms to long term
      survival have not be explored. Therefore, this prospective, observational cohort study aimed
      to explore the influence of anxiety and depression to long term survival in NPC patients.
observational model: Cohort
time perspective: Prospective
measure: Progress-free survival
time frame: 3 years
description: Progress-free survival is calculated from the date of registration to the date of the first progress at any site.
measure: Anxiety related measure
time frame: Baseline, completion of radiation therapy (up to 12 weeks)
description: Hospital Anxiety and Depression Scale (HADS) and Hamilton Anxiety Rating Scale (HAMA) will be used during the assessment.
measure: Distress related measure
time frame: Baseline, completion of radiation therapy (up to 12 weeks)
description: Hospital Anxiety and Depression Scale (HADS) and Hamilton Depression Rating Scale (HAMD) will be used during the assessment.
measure: Overall Survival(OS)
time frame: 3 years
description: The OS was defined as the duration from the date of registration assignment to the date of death from any cause or censored at the date of the last follow-up.
measure: Locoregional Relapse-Free Survival(LRFS)
time frame: 3 years
description: The LRFS is evaluated and calculated from the date of registration until the day of first locoregional relapse or until the date of the last follow-up visit.
measure: Distant Metastasis-Free Survival (DMFS)
time frame: 3 years
description: The DMFS is evaluated and calculated from the date of registration until the day of first distant metastases or until the date of the last follow-up visit.
measure: Complete Response (CR)
time frame: completion of radiation therapy (up to 12 weeks)
description: CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the treatment. Complete response defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
measure: Weight Loss
time frame: Baseline, completion of radiation therapy (up to 12 weeks)
description: Weight loss was calculated as the relative percent of weight changes between weight measurement before and after the nasopharyngeal carcinoma treatment. Weight loss was calculated from the following formula:（ pro-treatment body weight - post-treatment body weight）/ pro-treatment body weight.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: HaiQiang Mai
phone: 8620-8734-3380
email: maihq@sysucc.org.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Hai-Qiang Mai,MD,PhD
investigator title: Deputy Director of the Department of Nasopharyngeal Carcinoma
mesh term: Carcinoma
mesh term: Nasopharyngeal Carcinoma