<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/NCT03297723</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01405-46</org_study_id>
    <nct_id>NCT03297723</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management</brief_title>
  <acronym>EFFADOL-K</acronym>
  <official_title>Effectiveness of a Patient Therapeutic Education Program in Improving Pain Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Francois Baclesse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre Francois Baclesse</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 one of the most feared and burdensome symptoms experienced by cancer patients. Its&#xD;
      prevalence has been estimated by INCa1 in 2012 at 48% in patients undergoing cancer&#xD;
      treatment, and unrelieved pain is directly associated with significantly reduced quality of&#xD;
      life (QoL)2. A large part of cancer pain undertreatment can be attributed to patient-related&#xD;
      barriers. Patient barriers are multifactorial and often result from a lack of knowledge about&#xD;
      cancer pain and its self-management. They mainly consist of misconceptions about opioids and&#xD;
      their side effects, nonadherence, and reluctance to alert health care providers to unrelieved&#xD;
      pain. Patient education enables people with chronic disease to manage their illness, and has&#xD;
      been considered in the field of cancer research as an important strategy to achieve optimal&#xD;
      pain control.&#xD;
&#xD;
      In Basse-Normandie french region, the &quot;Health Regional Plan, pain aspect&quot; has identified the&#xD;
      theme &quot; pain education program &quot; as a priority.&#xD;
&#xD;
      The main endpoint is the decrease of pain interference with daily life (using the Brief Pain&#xD;
      Inventory). The experimental group, consisting of cancer pain patients, will benefit from the&#xD;
      education program by previously trained health care providers. It will be compared with the&#xD;
      control group, consisting with patients whose pain will be conventionally managed before the&#xD;
      professional training in therapeutic education.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 18, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>the decrease of pain impact on daily life activities based on a decrease of 2 points (on a 0-10 scale) between mean values measured before and after the PEP (at 1 month).</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The proportion of patients adhering to the full ETP program (3 workshops),</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Pain Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <description>The experimental group will be constituted after the medical staff was trained to TPE. Cancer patients will benefit from a PEP aiming at learning how to better manage their pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controle arm</arm_group_label>
    <description>The control group will be constituted before the training of the medical staff to TPE. Patients' pain will be managed conventionally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Therapeutic education Programm</intervention_name>
    <description>Intervention will include:&#xD;
an identification of educational needs and expectations,&#xD;
a bilateral agreement between patient and medical staff on the priority skills acquirement,&#xD;
a structured educational activities tailored to the patient's need.&#xD;
the making of an educational record.</description>
    <arm_group_label>Experimental arm</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient suffering from a cancer and suffering from pain&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient suffering from a cancer which diagnosis has been established since at least 1&#xD;
             month&#xD;
&#xD;
          -  Patient who suffers from pain related to the pathology or its treatment:&#xD;
&#xD;
          -  receiving an analgesic treatment since at least 1 month&#xD;
&#xD;
          -  moderate to severe pain intensity in the previous week : average pain score greater&#xD;
             than 4 (on a 0-10 numerical rating scale), OR pain leading to insomnia OR 4 daily&#xD;
             breakthrough pain, which interferes with daily activities&#xD;
&#xD;
          -  Patient with a life expectancy &gt; or = 6 months&#xD;
&#xD;
          -  Health compatible with the PEP requirements (WHO performance scale &gt; or = 2)&#xD;
&#xD;
          -  Patient v 18 years old&#xD;
&#xD;
          -  Patient able to understand, speak and read French&#xD;
&#xD;
          -  Patient without cognitive dysfunctions&#xD;
&#xD;
          -  Patient with a signed informed consent before inclusion in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary central nervous system or cerebral metastases&#xD;
&#xD;
          -  Disorders of higher functions documented&#xD;
&#xD;
          -  Evolutionary psychiatric pathology&#xD;
&#xD;
          -  Drug user&#xD;
&#xD;
          -  Abuse of alcohol exceeding WHO recommendations&#xD;
&#xD;
          -  Refusal of participation&#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_contact>
    <last_name>Claire DELORME, MD</last_name>
    <phone>0231455050</phone>
    <email>c.delorme@baclesse.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Virginie PREVOST, Pharm D</last_name>
    <phone>0231455050</phone>
    <email>virginie.prevost@unicaen.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>centre Hospitalier d'Alençon</name>
      <address>
        <city>Alençon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sonia CAUCHIN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier d'Argentan</name>
      <address>
        <city>Argentan</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Christine LE GAL, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier AVRANCHES-GRANVILLE</name>
      <address>
        <city>Avranches</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marie-Claude ROPARTZ, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Bayeux</name>
      <address>
        <city>Bayeux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Claire DELORME, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre François Baclesse</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marie-Christine GRACH, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU CAEN</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marjorie LOAEC, MD</last_name>
    </contact>
    <investigator>
      <last_name>Marjorie LOAEC, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital privé Paul d'Egine</name>
      <address>
        <city>Champigny-sur-Marne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Freddy KAYEMBE, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Cherbourg</name>
      <address>
        <city>Cherbourg-Octeville</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Laure KALUZINSKI, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ch Dieppe</name>
      <address>
        <city>Dieppe</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne-Laure QUESNEL, MD</last_name>
    </contact>
    <investigator>
      <last_name>Anne-Laure QUESNEL, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Flers</name>
      <address>
        <city>Flers</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Franck LE CAER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Lisieux</name>
      <address>
        <city>Lisieux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Virith SEP HIENG, MD</last_name>
    </contact>
    <investigator>
      <last_name>Virith SEP HIENG, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hopital Européen Georges Pompidou (HEGP)</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alexandre SAADI, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Saint-lo</name>
      <address>
        <city>Saint-Lô</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Maryline FEUILLET, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ghpso Senlis</name>
      <address>
        <city>Senlis</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gwladys FONTAINE, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>IGR</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sophie LAURENT, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>May 17, 2021</last_update_submitted>
  <last_update_submitted_qc>May 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03297723
org study id: 2016-A01405-46
nct id: NCT03297723
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pain is one of the most feared and burdensome symptoms experienced by cancer patients. Its
      prevalence has been estimated by INCa1 in 2012 at 48% in patients undergoing cancer
      treatment, and unrelieved pain is directly associated with significantly reduced quality of
      life (QoL)2. A large part of cancer pain undertreatment can be attributed to patient-related
      barriers. Patient barriers are multifactorial and often result from a lack of knowledge about
      cancer pain and its self-management. They mainly consist of misconceptions about opioids and
      their side effects, nonadherence, and reluctance to alert health care providers to unrelieved
      pain. Patient education enables people with chronic disease to manage their illness, and has
      been considered in the field of cancer research as an important strategy to achieve optimal
      pain control.

      In Basse-Normandie french region, the "Health Regional Plan, pain aspect" has identified the
      theme " pain education program " as a priority.

      The main endpoint is the decrease of pain interference with daily life (using the Brief Pain
      Inventory). The experimental group, consisting of cancer pain patients, will benefit from the
      education program by previously trained health care providers. It will be compared with the
      control group, consisting with patients whose pain will be conventionally managed before the
      professional training in therapeutic education.
observational model: Cohort
time perspective: Prospective
measure: the decrease of pain impact on daily life activities based on a decrease of 2 points (on a 0-10 scale) between mean values measured before and after the PEP (at 1 month).
time frame: 1 month
measure: The proportion of patients adhering to the full ETP program (3 workshops),
time frame: 1 month
arm group label: Experimental arm
description: The experimental group will be constituted after the medical staff was trained to TPE. Cancer patients will benefit from a PEP aiming at learning how to better manage their pain.
arm group label: Controle arm
description: The control group will be constituted before the training of the medical staff to TPE. Patients' pain will be managed conventionally.
intervention type: Other
intervention name: Therapeutic education Programm
description: Intervention will include:
an identification of educational needs and expectations,
a bilateral agreement between patient and medical staff on the priority skills acquirement,
a structured educational activities tailored to the patient's need.
the making of an educational record.
arm group label: Experimental arm
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claire DELORME, MD
phone: 0231455050
email: c.delorme@baclesse.unicancer.fr
last name: Virginie PREVOST, Pharm D
phone: 0231455050
email: virginie.prevost@unicaen.fr
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
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status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
investigator: 
country: France
responsible party type: Sponsor
sharing ipd: No