<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/NCT01675505</url>
  </required_header>
  <id_info>
    <org_study_id>Phd Antoniadis</org_study_id>
    <nct_id>NCT01675505</nct_id>
  </id_info>
  <brief_title>Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery</brief_title>
  <official_title>Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aristotle University Of Thessaloniki</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aristotle University Of Thessaloniki</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate whether there are prognostic factors regarding the&#xD;
      mental and functional adjustment of colon cancer patients following curative surgery.&#xD;
      Patients will be selected using specific inclusion criteria. Prognostic factors investigated&#xD;
      include personality characteristics, initial distress, medical, social and economic factors.&#xD;
      The utmost purpose of the study is to assist clinicians with the timely identification of&#xD;
      vulnerable patients in order to ensure their proper management and their optimal adjustment.&#xD;
&#xD;
      Moreover this is the first study using the Distress Thermometer in Greek patients with&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2012</start_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>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Adaptation, Psychological</condition>
  <condition>Functional Insufficiency</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Inclusion criteria:&#xD;
Patients with first-diagnosed colon cancer. Age 18-60 y.o.&#xD;
Exclusion criteria:&#xD;
Metastatic colon cancer. Former psychiatric history. Substance use. Previous serious medical conditions.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Greek population from Northern Greece who are diagnosed with colon cancer for the first&#xD;
        time and are admitted to the 1st Propedeutic Surgical Department of AHEPA General&#xD;
        University Hospital of Thessaloniki for surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with first-diagnosed colon cancer.&#xD;
&#xD;
          -  Age 18-60 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metastatic colon cancer.&#xD;
&#xD;
          -  Former psychiatric history.&#xD;
&#xD;
          -  Substance use.&#xD;
&#xD;
          -  Previous serious medical conditions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Diomidis Antoniadis, Phd Student</last_name>
    <phone>00306993944616</phone>
    <email>dio_psych@yahoo.gr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Greece, 1st Propedeutic Surgical Department, AHEPA General University Hospital</name>
      <address>
        <city>Thessaloniki</city>
        <zip>54636</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diomidis Antoniadis, Phd Student</last_name>
      <phone>00306993944616</phone>
      <email>dio_psych@yahoo.gr</email>
    </contact>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <reference>
    <citation>Jimmie C. Holland, William S. Breitbart, Paul B.Jacobsen, Marguerite S. Lederberg, Matthew J. Loscalzo, Ruth McCorkle. Psycho-oncology, second edition, Oxford University Press, 2010 National Comprehensive Cancer Network. Distress management. Clinical practice guidelines. J Natl Compr Canc Netw. 2003;1:344-74. Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999;8:181-95. Watson M, Law M, dos Santos M, Greer S, Baruch J, Bliss J. The Mini-MAC: further development of the Mental Adjustment to Cancer Scale. J Psychosoc Oncol1994;12:33-46.</citation>
  </reference>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>July 9, 2013</last_update_submitted>
  <last_update_submitted_qc>July 9, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 11, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aristotle University Of Thessaloniki</investigator_affiliation>
    <investigator_full_name>Antoniadis Diomidis</investigator_full_name>
    <investigator_title>Phd student</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT01675505
org study id: Phd Antoniadis
nct id: NCT01675505
lead sponsor: 
has dmc: Yes
The purpose of the study is to investigate whether there are prognostic factors regarding the
      mental and functional adjustment of colon cancer patients following curative surgery.
      Patients will be selected using specific inclusion criteria. Prognostic factors investigated
      include personality characteristics, initial distress, medical, social and economic factors.
      The utmost purpose of the study is to assist clinicians with the timely identification of
      vulnerable patients in order to ensure their proper management and their optimal adjustment.

      Moreover this is the first study using the Distress Thermometer in Greek patients with
      cancer.
observational model: Cohort
time perspective: Prospective
arm group label: Patients
description: Inclusion criteria:
Patients with first-diagnosed colon cancer. Age 18-60 y.o.
Exclusion criteria:
Metastatic colon cancer. Former psychiatric history. Substance use. Previous serious medical conditions.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Diomidis Antoniadis, Phd Student
phone: 00306993944616
email: dio_psych@yahoo.gr
facility: 
status: Recruiting
contact: 
country: Greece
citation: Jimmie C. Holland, William S. Breitbart, Paul B.Jacobsen, Marguerite S. Lederberg, Matthew J. Loscalzo, Ruth McCorkle. Psycho-oncology, second edition, Oxford University Press, 2010 National Comprehensive Cancer Network. Distress management. Clinical practice guidelines. J Natl Compr Canc Netw. 2003;1:344-74. Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999;8:181-95. Watson M, Law M, dos Santos M, Greer S, Baruch J, Bliss J. The Mini-MAC: further development of the Mental Adjustment to Cancer Scale. J Psychosoc Oncol1994;12:33-46.
responsible party type: Principal Investigator
investigator affiliation: Aristotle University Of Thessaloniki
investigator full name: Antoniadis Diomidis
investigator title: Phd student
mesh term: Colorectal Neoplasms