<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/NCT04404920</url>
  </required_header>
  <id_info>
    <org_study_id>OASis study</org_study_id>
    <nct_id>NCT04404920</nct_id>
  </id_info>
  <brief_title>Oral Assessment of Symptoms in Advanced Cancer</brief_title>
  <acronym>OASis</acronym>
  <official_title>An Observational Study of the Frequency of Oral Symptoms in Patients With Advanced Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal Surrey County Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal Surrey County Hospital NHS Foundation Trust</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>
      Observational study of prevalence of oral symptoms in patients with advanced cancer using a&#xD;
      novel questionnaire (&quot;Oral symptom assessment scale&quot;)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A novel questionnaire (the &quot;Oral symptom assessment scale&quot; / OSAS) has been developed to&#xD;
      assess a range of oral symptoms in patients with advanced cancer.&#xD;
&#xD;
      The OSAS consists of 20 symptoms, which were chosen following a review of the literature /&#xD;
      discussion with experts in the field. The OSAS was modelled on the Memorial Symptom&#xD;
      Assessment Scale (MSAS), and asks about the presence of the symptoms, the frequency of the&#xD;
      symptoms (i.e. &quot;rarely&quot;; &quot;occasionally&quot;; &quot;frequently&quot;; or &quot;almost constantly&quot;), the severity&#xD;
      of the symptoms (i.e. &quot;slight&quot;; &quot;moderate&quot;; &quot;severe&quot;; or &quot;very severe&quot;), and how much&#xD;
      distress they cause (i.e. &quot;not at all&quot;; &quot;a little bit&quot;; &quot;somewhat&quot;; &quot;quite a bit&quot;; or &quot;very&#xD;
      much&quot;). The questions relate to the last week.&#xD;
&#xD;
      Patients will be given the OSAS to complete, and also the short form of the MSAS (which asks&#xD;
      about the presence, and related distress, of 32 physical / psychological symptoms, including&#xD;
      a small number of oral symptoms). Demographic data, cancer diagnosis, and performance status&#xD;
      will also be collected. The study involves a single visit / assessment.&#xD;
&#xD;
      Descriptive statistics will be used to present the data, and hierarchical cluster analysis&#xD;
      will be used to identify oral symptom clusters. Kappa tests will be used to compare analogous&#xD;
      questions on the OSAS and short form MSAS (as part of the validation of the OSAS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 3, 2014</start_date>
  <completion_date type="Actual">July 30, 2015</completion_date>
  <primary_completion_date type="Actual">July 30, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of oral symptoms (20)</measure>
    <time_frame>1 week</time_frame>
    <description>Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of physical / psychological symptoms</measure>
    <time_frame>1 week</time_frame>
    <description>Questionnaire</description>
  </secondary_outcome>
  <enrollment type="Actual">253</enrollment>
  <condition>Oral Complication</condition>
  <condition>Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Novel questionnaire about oral symptoms (&quot;Oral symptom assessment scale / OSAS), and validated questionnaire about physical and psychological symptoms (Memorial Symptom Assessment Scale / MSAS).</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        250 subjects that are either inpatients or outpatients at study sites (hospital and&#xD;
        hospices in the United Kingdom).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt; 18yr; diagnosis of locally advanced / metastatic cancer; already known to the&#xD;
             specialist palliative care team&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to give informed consent; inability to complete questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Davies, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Surrey County Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Brighton &amp; Sussex University Hospitals</name>
      <address>
        <city>Brighton</city>
        <state>East Sussex</state>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>East Sussex Healthcare NHS Trust</name>
      <address>
        <city>Eastbourne</city>
        <state>East Sussex</state>
        <zip>BN21 2UD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pilgrims Hospice</name>
      <address>
        <city>Margate</city>
        <state>Kent</state>
        <zip>CT9 4AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ellenor Lions Hospice</name>
      <address>
        <city>Northfleet</city>
        <state>Kent</state>
        <zip>DA11 7HQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospice in the Weald</name>
      <address>
        <city>Pembury</city>
        <state>Kent</state>
        <zip>TN2 4TA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wisdom Hospice</name>
      <address>
        <city>Rochester</city>
        <state>Kent</state>
        <zip>ME1 2NU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frimley Park Hospital</name>
      <address>
        <city>Camberley</city>
        <state>Surrey</state>
        <zip>GU16 7UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alice Hospice</name>
      <address>
        <city>Esher</city>
        <state>Surrey</state>
        <zip>KT10 9RL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Surrey County Hospital</name>
      <address>
        <city>Guildford</city>
        <state>Surrey</state>
        <zip>GU2 7XX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Wilfred's Hospice</name>
      <address>
        <city>Chichester</city>
        <state>Wesr Sussex</state>
        <zip>PO18 8QB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Catherine's Hospice</name>
      <address>
        <city>Crawley</city>
        <state>West Sussex</state>
        <zip>RH10 6BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.</citation>
    <PMID>10964347</PMID>
  </results_reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral symptoms</keyword>
  <keyword>Cancer</keyword>
  <keyword>Palliative care</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Currently, there are no plans to make IPD available to other researchers</ipd_description>
  </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/NCT04404920
org study id: OASis study
nct id: NCT04404920
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Observational study of prevalence of oral symptoms in patients with advanced cancer using a
      novel questionnaire ("Oral symptom assessment scale")
A novel questionnaire (the "Oral symptom assessment scale" / OSAS) has been developed to
      assess a range of oral symptoms in patients with advanced cancer.

      The OSAS consists of 20 symptoms, which were chosen following a review of the literature /
      discussion with experts in the field. The OSAS was modelled on the Memorial Symptom
      Assessment Scale (MSAS), and asks about the presence of the symptoms, the frequency of the
      symptoms (i.e. "rarely"; "occasionally"; "frequently"; or "almost constantly"), the severity
      of the symptoms (i.e. "slight"; "moderate"; "severe"; or "very severe"), and how much
      distress they cause (i.e. "not at all"; "a little bit"; "somewhat"; "quite a bit"; or "very
      much"). The questions relate to the last week.

      Patients will be given the OSAS to complete, and also the short form of the MSAS (which asks
      about the presence, and related distress, of 32 physical / psychological symptoms, including
      a small number of oral symptoms). Demographic data, cancer diagnosis, and performance status
      will also be collected. The study involves a single visit / assessment.

      Descriptive statistics will be used to present the data, and hierarchical cluster analysis
      will be used to identify oral symptom clusters. Kappa tests will be used to compare analogous
      questions on the OSAS and short form MSAS (as part of the validation of the OSAS).
observational model: Other
time perspective: Cross-Sectional
measure: Prevalence of oral symptoms (20)
time frame: 1 week
description: Questionnaire
measure: Prevalence of physical / psychological symptoms
time frame: 1 week
description: Questionnaire
intervention type: Other
intervention name: Questionnaire
description: Novel questionnaire about oral symptoms ("Oral symptom assessment scale / OSAS), and validated questionnaire about physical and psychological symptoms (Memorial Symptom Assessment Scale / MSAS).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Davies, MD
role: Principal Investigator
affiliation: Royal Surrey County Hospital NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
citation: Chang VT, Hwang SS, Feuerman M, Kasimis BS, Thaler HT. The memorial symptom assessment scale short form (MSAS-SF). Cancer. 2000 Sep 1;89(5):1162-71. doi: 10.1002/1097-0142(20000901)89:53.0.co;2-y.
PMID: 10964347
responsible party type: Sponsor
sharing ipd: No
ipd description: Currently, there are no plans to make IPD available to other researchers