<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/NCT03818230</url>
  </required_header>
  <id_info>
    <org_study_id>NHS001389</org_study_id>
    <nct_id>NCT03818230</nct_id>
  </id_info>
  <brief_title>An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.</brief_title>
  <acronym>EPIC</acronym>
  <official_title>An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Christie NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</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 is an exploratory prospective observational cohort study to establish the levels of&#xD;
      psychological distress in early phase clinical trial patients and evaluate the psychological&#xD;
      impact of early phase clinical trials on cancer patients. Participants will be requested to&#xD;
      complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at&#xD;
      different time points along the clinical trials pathway.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 21, 2018</start_date>
  <completion_date type="Actual">November 15, 2019</completion_date>
  <primary_completion_date type="Actual">November 15, 2019</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>Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.</measure>
    <time_frame>Approximately 14 weeks.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Levels of hope as per the Adult Hope Scale.</measure>
    <time_frame>Approximately 14 weeks.</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">64</enrollment>
  <condition>Cancer</condition>
  <condition>Depression</condition>
  <condition>Anxiety</condition>
  <condition>Hope</condition>
  <condition>Psychological Distress</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>None (observational study)</intervention_name>
    <description>None (observational study)</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who have been referred to the Experimental Cancer Medicine Team (ECMT) at The&#xD;
        Christie NHS Foundation Trust, to be considered for participation in an early phase&#xD;
        clinical trial.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 years and older&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Are being considered for an early phase clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to comprehend English language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>March 23, 2020</last_update_submitted>
  <last_update_submitted_qc>March 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Dr Natalie Cook</investigator_full_name>
    <investigator_title>Honorary Consultant in Medical Oncology</investigator_title>
  </responsible_party>
  <keyword>Clinical trials</keyword>
  <keyword>Early phase clinical trials</keyword>
  <keyword>Experimental cancer medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03818230
org study id: NHS001389
nct id: NCT03818230
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is an exploratory prospective observational cohort study to establish the levels of
      psychological distress in early phase clinical trial patients and evaluate the psychological
      impact of early phase clinical trials on cancer patients. Participants will be requested to
      complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at
      different time points along the clinical trials pathway.
observational model: Cohort
time perspective: Prospective
measure: Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.
time frame: Approximately 14 weeks.
measure: Levels of hope as per the Adult Hope Scale.
time frame: Approximately 14 weeks.
intervention type: Other
intervention name: None (observational study)
description: None (observational study)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Dr Natalie Cook
investigator title: Honorary Consultant in Medical Oncology
mesh term: Depression
sharing ipd: No