<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/NCT04468490</url>
  </required_header>
  <id_info>
    <org_study_id>155(A)WO19191</org_study_id>
    <nct_id>NCT04468490</nct_id>
  </id_info>
  <brief_title>Treatment of Breakthrough Cancer Pain According to European Guidelines</brief_title>
  <acronym>BEG</acronym>
  <official_title>Adherence to Breakthrough Cancer Pain (BTcP) European Guidelines: an Observational Prospective Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aziende Chimiche Riunite Angelini Francesco S.p.A</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aziende Chimiche Riunite Angelini Francesco S.p.A</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>
      Pain is a frequent symptom in cancer patients with a negative impact on the quality of life&#xD;
      (QoL).Breakthrough cancer pain (BTcP) is defined as &quot;a transient exacerbation of pain,&#xD;
      manifesting spontaneously or related to a specific predictable or unpredictable triggering&#xD;
      factor, despite stable and adequately controlled basal pain&quot;. The present study assesses the&#xD;
      percentage of patients who are treated according to the European guidelines (ESMO, 2018) for&#xD;
      BTcP management in 4 European countries and the impact of the adherence to guidelines on&#xD;
      patients' pain relief and QoL.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe&#xD;
      intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP&#xD;
      requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with&#xD;
      breakthrough pain should have this pain specifically assessed, starting from the appropriate&#xD;
      diagnosis. Recently developed European guidelines support this approach and recommend&#xD;
      treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick&#xD;
      start and short duration of the pain episode.Nevertheless, despite the drug treatment for&#xD;
      BTcP has undergone knowledge advances in recent years and several guidelines have been&#xD;
      published, this condition is still often inadequately managed.&#xD;
&#xD;
      The present study will assess the percentage of patients who are treated according to the&#xD;
      European guidelines for BTcP management in 4 European countries and the impact of the&#xD;
      adherence to guidelines on patients' pain relief and QoL.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrollment rate&#xD;
  </why_stopped>
  <start_date type="Actual">August 11, 2020</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.</measure>
    <time_frame>4 weeks of observation</time_frame>
    <description>Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>APM algorithm</measure>
    <time_frame>0, 1, 2, 3, 4 weeks of observation</time_frame>
    <description>BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tool-BAT</measure>
    <time_frame>at 0, 1, 2, 3, 4 weeks of observation</time_frame>
    <description>BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EORTC QLQ-C30</measure>
    <time_frame>at 0, 1, 2, 3, 4 weeks of observation</time_frame>
    <description>Quality of life assessed by the questionnaire EORTC: 28 questions from 1 to 4 (there are not wrong or right answers) + 2 questions from 7 point scales from 1 (very poor) to 7 (excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Change (PGIC)</measure>
    <time_frame>at 0, 2 and 4 weeks of observation</time_frame>
    <description>Global impression of clinical condition assessed by the Patient through 7 point scales from 1 (very much improved) to 7 (very much worse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)</measure>
    <time_frame>at 2 and 4 weeks of observation</time_frame>
    <description>Number of specialist/GP visits due to cancer pain during the observation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resources consumed due to cancer pain (Number of hospitalizations)</measure>
    <time_frame>at 2 and 4 weeks of observation</time_frame>
    <description>Number of hospitalizations due to cancer pain during the observation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resources consumed due to cancer pain (Length of hospitalizations)</measure>
    <time_frame>at 2 and 4 weeks of observation</time_frame>
    <description>Length of hospitalizations (days) due to cancer pain during the observation period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)</measure>
    <time_frame>at 2 and 4 weeks of observation</time_frame>
    <description>Number of admittances to ER due to cancer pain during the observation period</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">131</enrollment>
  <condition>Breakthrough Cancer Pain</condition>
  <arm_group>
    <arm_group_label>GROUP A: Patients adherent to BTcP European Guidelines</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>GROUP B: Patients non Adherent to BTcP European Guidelines</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population includes patients with BTcP.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients of any ethnic origin of ≥ 18 years.&#xD;
&#xD;
          -  Patients diagnosed with locally advanced or recurrent metastatic cancer (histologic or&#xD;
             cytologic diagnosis), with BTcP, as assessed by the Investigator.&#xD;
&#xD;
          -  Opioid-tolerant patients receiving doses of oral morphine equivalent daily doses&#xD;
             (OMEDD) of at least 60 mg.&#xD;
&#xD;
          -  Drugs for BTcP treatment, if any, must be used according to the relevant SmPC.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status with a score of 0, or 1,&#xD;
             or 2.&#xD;
&#xD;
          -  Patients with life expectancy &gt; 3 months.&#xD;
&#xD;
          -  Patients legally capable of giving their consent to participate in the study and&#xD;
             available to sign and date the written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous or current history of a clinically significant&#xD;
             neurological/psychiatric disorder and/or any substance abuse or dependence that,&#xD;
             according to the Investigator's judgement, can impair the study end-points/results.&#xD;
&#xD;
          -  Patients who have been taking antidepressants and/or drugs acting on pain and who take&#xD;
             them on a regular basis during the observation period, can be enrolled.&#xD;
&#xD;
          -  Any medical condition or situation complicating the collection of study data, as&#xD;
             determined by the Investigator.&#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>Nzoz Zespół Medyczno Opiekuńczy Alicja Kluczna</name>
      <address>
        <city>Dąbrowa Górnicza</city>
        <zip>41-300</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>October 20, 2021</last_update_submitted>
  <last_update_submitted_qc>October 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breakthrough cancer pain</keyword>
  <keyword>Cancer</keyword>
  <keyword>BTcP</keyword>
  <keyword>Background pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cancer Pain</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/NCT04468490
org study id: 155(A)WO19191
nct id: NCT04468490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain is a frequent symptom in cancer patients with a negative impact on the quality of life
      (QoL).Breakthrough cancer pain (BTcP) is defined as "a transient exacerbation of pain,
      manifesting spontaneously or related to a specific predictable or unpredictable triggering
      factor, despite stable and adequately controlled basal pain". The present study assesses the
      percentage of patients who are treated according to the European guidelines (ESMO, 2018) for
      BTcP management in 4 European countries and the impact of the adherence to guidelines on
      patients' pain relief and QoL.
Typical BTcP episodes are of short duration (15-30 minutes/episode), moderate to severe
      intensity and rapid onset (maximum peak between 3-15 minutes). The best management of BTcP
      requires a thorough evaluation to tailor the treatment strategies. Indeed, patients with
      breakthrough pain should have this pain specifically assessed, starting from the appropriate
      diagnosis. Recently developed European guidelines support this approach and recommend
      treating BTcP using rapid-onset opioids (ROOs), with pharmacodynamics that mirror the quick
      start and short duration of the pain episode.Nevertheless, despite the drug treatment for
      BTcP has undergone knowledge advances in recent years and several guidelines have been
      published, this condition is still often inadequately managed.

      The present study will assess the percentage of patients who are treated according to the
      European guidelines for BTcP management in 4 European countries and the impact of the
      adherence to guidelines on patients' pain relief and QoL.
observational model: Other
time perspective: Prospective
measure: Percentage of patients treated according to 2018 ESMO European Guideline guidelines for BTcP.
time frame: 4 weeks of observation
description: Percentage of BTcP treatment guideline adherent vs non-adherent patients, in the 4 weeks of observation (V2)
measure: APM algorithm
time frame: 0, 1, 2, 3, 4 weeks of observation
description: BTcP diagnosis by APM algorithm observation (V0, telephone contact1, V1, telephone contact2, V2)
measure: Tool-BAT
time frame: at 0, 1, 2, 3, 4 weeks of observation
description: BTcP assessment by Tool-BAT (V0, telephone contact1, V1, telephone contact2, V2)
measure: EORTC QLQ-C30
time frame: at 0, 1, 2, 3, 4 weeks of observation
description: Quality of life assessed by the questionnaire EORTC: 28 questions from 1 to 4 (there are not wrong or right answers) + 2 questions from 7 point scales from 1 (very poor) to 7 (excellent)
measure: Patient Global Impression of Change (PGIC)
time frame: at 0, 2 and 4 weeks of observation
description: Global impression of clinical condition assessed by the Patient through 7 point scales from 1 (very much improved) to 7 (very much worse).
measure: Healthcare resources consumed due to cancer pain (Number of specialist/GP visits)
time frame: at 2 and 4 weeks of observation
description: Number of specialist/GP visits due to cancer pain during the observation period
measure: Healthcare resources consumed due to cancer pain (Number of hospitalizations)
time frame: at 2 and 4 weeks of observation
description: Number of hospitalizations due to cancer pain during the observation period
measure: Healthcare resources consumed due to cancer pain (Length of hospitalizations)
time frame: at 2 and 4 weeks of observation
description: Length of hospitalizations (days) due to cancer pain during the observation period
measure: Healthcare resources consumed due to cancer pain (Number of admittances to ER) due to cancer pain)
time frame: at 2 and 4 weeks of observation
description: Number of admittances to ER due to cancer pain during the observation period
arm group label: GROUP A: Patients adherent to BTcP European Guidelines
arm group label: GROUP B: Patients non Adherent to BTcP European Guidelines
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Cancer Pain
sharing ipd: No