<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/NCT03813719</url>
  </required_header>
  <id_info>
    <org_study_id>16HH3687 Psych Study EC</org_study_id>
    <nct_id>NCT03813719</nct_id>
  </id_info>
  <brief_title>Anxiety and Distress Levels in Women With Suspected Endometrial Cancer</brief_title>
  <official_title>Anxiety and Distress Levels in Women With Suspected Endometrial Cancer Seen in the Rapid Access Gynaecology Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</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>
      Patients attending the rapid access gynaecology clinic with a suspicion of endometrial cancer&#xD;
      are understandably nervous. Few studies have quantified anxiety and distress of patients in&#xD;
      this group.&#xD;
&#xD;
      This study surveys anxiety and stress levels of women attending clinic (by filling in an&#xD;
      anonymous questionnaire). Additionally, in women who need a tissue biopsy, women are asked to&#xD;
      rate their pain scores.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aims:&#xD;
&#xD;
      Quantify the anxiety and stress levels of women attending the Rapid access gynaecology clinic&#xD;
      with a suspicion of cancer&#xD;
&#xD;
      Background:&#xD;
&#xD;
      Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most&#xD;
      common gynaecological cancer in the United Kingdom (UK). In 2012, there were almost 100,000&#xD;
      new cases diagnosed in Europe. Endometrial cancer classically presents with postmenopausal&#xD;
      bleeding (bleeding after the menopause), or intermenstrual bleeding (bleeding in between&#xD;
      periods).&#xD;
&#xD;
      Although routine management for these women does vary, in general a screening test is&#xD;
      performed, typically a pelvic (internal) ultrasound to assess the endometrium (womb lining).&#xD;
      In cases where the endometrial thickness is above the threshold for investigation -an&#xD;
      endometrial biopsy (sampling cells from the womb lining) is indicated. Whilst well tolerated,&#xD;
      this can be quite painful.&#xD;
&#xD;
      Once the endometrial biopsy is performed, it is sent to the histologist for further&#xD;
      examination. Histological analysis may take several days and patients are either brought back&#xD;
      to clinic for discussion of the results or are given a telephone appointment. The patient&#xD;
      often will not know the result of the test for up to 2 weeks; thus causing a lot of&#xD;
      unnecessary anxiety and distress.&#xD;
&#xD;
      The study:&#xD;
&#xD;
      Patients attending the Rapid Access Gynaecology Clinic will be invited to participate in the&#xD;
      study by filling in a short anonymous survey.&#xD;
&#xD;
      Additionally, patients undergoing a tissue biopsy sample will be asked to provide a pain&#xD;
      score, followed by a brief interview to ascertain if they would undergo the procedure again&#xD;
      if it was needed and how they tolerated the procedure. Additionally, the time taken to&#xD;
      perform the procedure will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Anxiety Score for Patients Attending Clinic</measure>
    <time_frame>Immediately before clinic (waiting room)</time_frame>
    <description>GAD 7 score - (Generalised Anxiety Disorder assessment 7 score). 7 items each measured and score summated. Scale 0-21.Cut offs 0-5, 6-10, 11-15, 16+ correlate with anxiety score. Higher levels = worse anxiety</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Score if Needing a Tissue Biopsy</measure>
    <time_frame>Immediately after tissue sample taken.</time_frame>
    <description>Patients asked to rank Pain score (using visual analogue score standardised tool), 0 to 10 score, where 0 is no pain and 10 is the worst pain in their life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time Taken for Tissue Sample to be Performed</measure>
    <time_frame>During tissue biopsy time</time_frame>
    <description>Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">250</enrollment>
  <condition>Endometrial Cancer</condition>
  <condition>Cancer</condition>
  <condition>Uterine Cancer</condition>
  <condition>Anxiety</condition>
  <condition>Stress</condition>
  <condition>Psychological</condition>
  <arm_group>
    <arm_group_label>All patients attending Rapid access Gynaecology Clinic</arm_group_label>
    <description>All patients attending Rapid access Gynaecology Clinic for the first time.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All women attending Rapid access gynaecology clinic in imperial College NHS trust&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All women presenting to rapid access gynaecology clinic with suspected gynaecological&#xD;
             cancer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone lacking capacity.&#xD;
&#xD;
          -  &lt;18years old.&#xD;
&#xD;
          -  Pregnant.&#xD;
&#xD;
          -  Anyone unable to understand English (in absence of translator)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Study on suspected endometrial cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Queen Charlotte and Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <results_first_submitted>June 5, 2020</results_first_submitted>
  <results_first_submitted_qc>July 13, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 14, 2020</results_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endometrial cancer</keyword>
  <keyword>cancer</keyword>
  <keyword>uterine cancer</keyword>
  <keyword>anxiety</keyword>
  <keyword>stress</keyword>
  <keyword>psychological</keyword>
  <keyword>survey</keyword>
  <keyword>point-of-care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Uterine Neoplasms</mesh_term>
    <mesh_term>Anxiety Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/19/NCT03813719/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Consective patients attending Rapid access Gynaecology Clinic for the first time, with suspected endometrial cancer between July 2018 and April 2019</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>All Patients Attending Rapid Access Gynaecology Clinic</title>
          <description>All patients attending Rapid access Gynaecology Clinic for the first time.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="250"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients recruited from 2 London hospitals</population>
      <group_list>
        <group group_id="B1">
          <title>All Patients Attending Rapid Access Gynaecology Clinic</title>
          <description>Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="250"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;30</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>30-39</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>40-49</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>50-59</title>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>60-69</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>70-79</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>80+</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="250"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/ethnicity</title>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="141"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black/Afro-carribean</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to say</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Anxiety Score for Patients Attending Clinic</title>
        <description>GAD 7 score - (Generalised Anxiety Disorder assessment 7 score). 7 items each measured and score summated. Scale 0-21.Cut offs 0-5, 6-10, 11-15, 16+ correlate with anxiety score. Higher levels = worse anxiety</description>
        <time_frame>Immediately before clinic (waiting room)</time_frame>
        <population>GAD 7 scores were calculated for each patient</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients Attending Rapid Access Gynaecology Clinic</title>
            <description>All patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.</description>
          </group>
        </group_list>
        <measure>
          <title>Anxiety Score for Patients Attending Clinic</title>
          <description>GAD 7 score - (Generalised Anxiety Disorder assessment 7 score). 7 items each measured and score summated. Scale 0-21.Cut offs 0-5, 6-10, 11-15, 16+ correlate with anxiety score. Higher levels = worse anxiety</description>
          <population>GAD 7 scores were calculated for each patient</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="3" upper_limit="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score if Needing a Tissue Biopsy</title>
        <description>Patients asked to rank Pain score (using visual analogue score standardised tool), 0 to 10 score, where 0 is no pain and 10 is the worst pain in their life.</description>
        <time_frame>Immediately after tissue sample taken.</time_frame>
        <population>Only 23 women required a tissue biopsy</population>
        <group_list>
          <group group_id="O1">
            <title>All Patients Attending Rapid Access Gynaecology Clinic</title>
            <description>Consecutive patients attending Rapid access Gynaecology Clinic for the first time with suspected endometrial cancer.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score if Needing a Tissue Biopsy</title>
          <description>Patients asked to rank Pain score (using visual analogue score standardised tool), 0 to 10 score, where 0 is no pain and 10 is the worst pain in their life.</description>
          <population>Only 23 women required a tissue biopsy</population>
          <units>score on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time Taken for Tissue Sample to be Performed</title>
        <description>Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.</description>
        <time_frame>During tissue biopsy time</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Patients Attending Rapid Access Gynaecology Clinic</title>
            <description>All patients attending Rapid access Gynaecology Clinic for the first time.</description>
          </group>
        </group_list>
        <measure>
          <title>Time Taken for Tissue Sample to be Performed</title>
          <description>Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.</description>
          <units>Minutes</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Survey and paired observational study. No additional interventions performed (pipelle biopsies were part of standard of care) so adverse effects specifically due to study should be zero. Having said that, the time and pain score for pipelle biopsies were observed and recorded as part of this study and complications for pipelle biopsy were recorded. Any complications for a tissue biopsy would be apparent immediately, so time frame post biopsy 20 minutes.</time_frame>
      <desc>Survey and Observational study.</desc>
      <group_list>
        <group group_id="E1">
          <title>All Patients Attending Rapid Access Gynaecology Clinic</title>
          <description>All patients attending Rapid access Gynaecology Clinic for the first time.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="250"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Diana Marcus</name_or_title>
      <organization>Imperial College London</organization>
      <phone>07525133957</phone>
      <email>d.marcus16@imperial.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03813719
org study id: 16HH3687 Psych Study EC
nct id: NCT03813719
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients attending the rapid access gynaecology clinic with a suspicion of endometrial cancer
      are understandably nervous. Few studies have quantified anxiety and distress of patients in
      this group.

      This study surveys anxiety and stress levels of women attending clinic (by filling in an
      anonymous questionnaire). Additionally, in women who need a tissue biopsy, women are asked to
      rate their pain scores.
Aims:

      Quantify the anxiety and stress levels of women attending the Rapid access gynaecology clinic
      with a suspicion of cancer

      Background:

      Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most
      common gynaecological cancer in the United Kingdom (UK). In 2012, there were almost 100,000
      new cases diagnosed in Europe. Endometrial cancer classically presents with postmenopausal
      bleeding (bleeding after the menopause), or intermenstrual bleeding (bleeding in between
      periods).

      Although routine management for these women does vary, in general a screening test is
      performed, typically a pelvic (internal) ultrasound to assess the endometrium (womb lining).
      In cases where the endometrial thickness is above the threshold for investigation -an
      endometrial biopsy (sampling cells from the womb lining) is indicated. Whilst well tolerated,
      this can be quite painful.

      Once the endometrial biopsy is performed, it is sent to the histologist for further
      examination. Histological analysis may take several days and patients are either brought back
      to clinic for discussion of the results or are given a telephone appointment. The patient
      often will not know the result of the test for up to 2 weeks; thus causing a lot of
      unnecessary anxiety and distress.

      The study:

      Patients attending the Rapid Access Gynaecology Clinic will be invited to participate in the
      study by filling in a short anonymous survey.

      Additionally, patients undergoing a tissue biopsy sample will be asked to provide a pain
      score, followed by a brief interview to ascertain if they would undergo the procedure again
      if it was needed and how they tolerated the procedure. Additionally, the time taken to
      perform the procedure will be recorded.
observational model: Cohort
time perspective: Prospective
measure: Anxiety Score for Patients Attending Clinic
time frame: Immediately before clinic (waiting room)
description: GAD 7 score - (Generalised Anxiety Disorder assessment 7 score). 7 items each measured and score summated. Scale 0-21.Cut offs 0-5, 6-10, 11-15, 16+ correlate with anxiety score. Higher levels = worse anxiety
measure: Pain Score if Needing a Tissue Biopsy
time frame: Immediately after tissue sample taken.
description: Patients asked to rank Pain score (using visual analogue score standardised tool), 0 to 10 score, where 0 is no pain and 10 is the worst pain in their life.
measure: Time Taken for Tissue Sample to be Performed
time frame: During tissue biopsy time
description: Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.
arm group label: All patients attending Rapid access Gynaecology Clinic
description: All patients attending Rapid access Gynaecology Clinic for the first time.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Study on suspected endometrial cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Endometrial Neoplasms
mesh term: Uterine Neoplasms
mesh term: Anxiety Disorders
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 