<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/NCT03296150</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL16_0149</org_study_id>
    <nct_id>NCT03296150</nct_id>
  </id_info>
  <brief_title>ADOPT-PRESTAGE: Study Evaluating the Impact of the Program PRESTAGE</brief_title>
  <acronym>ADOPT-PRESTAGE</acronym>
  <official_title>ADOPT-PRESTAGE: Randomized Controlled Trial on Acceptability, Diffusion and Impact on Treatment Adherence and Persistence of the PRESTAGE Program (Program for Education and Support for Oral Cancer Treatments in the Elderly) - Randomized Controlled Study Evaluating the Impact of the Program PRESTAGE</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      As the proportion of oral anticancer treatments is continuously increasing, adherence appears&#xD;
      as a major issue for patients' outcomes. Poor adherence affects particularly geriatric&#xD;
      patients due among others to polypharmacy or cognitive impairment. Thus, the need for&#xD;
      educational programs in this population has been regularly emphasized.&#xD;
&#xD;
      PRESTAGE educational program was built after an external and internal analysis of educational&#xD;
      needs in elderly patients treated with oral cancer treatments. It implicates a&#xD;
      multidisciplinary educational team (nurses, physicians, pharmacists, psychologists,&#xD;
      physiologists, social workers...). Six educational workshops were designed with the following&#xD;
      endpoints: disease and treatment understanding, treatment management, nutrition and&#xD;
      psychological as well as physical well being.&#xD;
&#xD;
      ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter,&#xD;
      randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to&#xD;
      the investigators' knowledge, the first randomized controlled trial evaluating the&#xD;
      acceptability and impact (adherence, clinical benefit) of an educational program in an&#xD;
      elderly cancer population. The primary endpoint of this trial will be to evaluate adherence&#xD;
      using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS).&#xD;
      Secondary endpoints include quality of life and evaluation of changes in patients' behaviors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 29, 2018</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adherence evaluated by MicroElectronic Monitoring System</measure>
    <time_frame>at 4 months (after intervention or information)</time_frame>
    <description>Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adherence evaluated by Morisky questionnaires</measure>
    <time_frame>4 months to 12 months</time_frame>
    <description>Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence evaluated by pharmacy medication refill -based adherence</measure>
    <time_frame>4 months to 12 months</time_frame>
    <description>Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire</measure>
    <time_frame>4 months to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire</measure>
    <time_frame>4 months to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related quality of life evaluated by the EORTC quality of life questionnaire</measure>
    <time_frame>4 months to 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in patients' behaviors evaluated by questionnaires</measure>
    <time_frame>4 months to 12 months</time_frame>
    <description>Beliefs about Medication questionnaire and satisfaction with medication questionnaires</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">139</enrollment>
  <condition>Cancer</condition>
  <condition>Oral Anticancer Drugs</condition>
  <arm_group>
    <arm_group_label>Control arm : Information</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will receive the usual standard information delivered to patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention arm : Therapeutic educational program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive the therapeutic educational program &quot;PRESTAGE&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PRESTAGE</intervention_name>
    <description>PRESTAGE educational program targets the acquisition by the patients and their caregivers of competencies in (1) a better understanding of their disease and (2) their treatment, (3) a better drug management, including both anticancer and supportive treatments, (4) maintenance of a good nutritional status, (5) general health and psychological well being and (6) physical well being. After an individual educational diagnosis, each patient will be proposed an individualized educational program consisting in 1 to 6 of these workshops. An individualized final interview - entitled educational synthesis - will assess patient's skills and satisfaction.</description>
    <arm_group_label>Intervention arm : Therapeutic educational program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 70 years,&#xD;
&#xD;
          -  For which oral anticancer therapy has been initiated within the previous 45 days or&#xD;
             will be started within 45 days&#xD;
&#xD;
          -  For any type of cancer, solid or hematologic, any stage&#xD;
&#xD;
          -  Estimated life expectancy&gt; 6 months&#xD;
&#xD;
          -  Affiliation to social security or equivalent&#xD;
&#xD;
          -  Patients who can answer questionnaires and protocol evaluations&#xD;
&#xD;
          -  Informed consent signed by patients&#xD;
&#xD;
          -  Domiciled within 50 km around the investigating center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For patients with breast cancer, exclusive treatment with hormone therapy&#xD;
&#xD;
          -  First-generation Hormone Therapy in Prostate Cancer&#xD;
&#xD;
          -  Patient not available for regular follow-up whatever the cause (geographic, family,&#xD;
             social, psychological)&#xD;
&#xD;
          -  Any serious condition, ie serious physical or mental, leading to a disability&#xD;
             permanent and likely to prevent the proper course of treatment&#xD;
&#xD;
          -  Patient deprived of liberty or under guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Olivia LE SAUX</last_name>
    <role>Study Chair</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Olivia LE SAUX</last_name>
    <phone>04 78 86 37 75</phone>
    <phone_ext>+33</phone_ext>
    <email>olivia.lesaux@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Claire FALANDRY, MD</last_name>
    <phone>04 78 86 15 80</phone>
    <phone_ext>+33</phone_ext>
    <email>claire.falandry@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service de neuro-oncologie, Hôpital Pierre Wertheimer, HCL</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>François DUCRAY, MD</last_name>
      <email>francois.ducray@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>François DUCRAY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service de Gériatrie, Centre Hospitalier de Givors</name>
      <address>
        <city>Givors</city>
        <zip>69700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youri CHAULEUR, MD</last_name>
      <email>ychauleur@ch-givors.fr</email>
    </contact>
    <investigator>
      <last_name>Youri CHAULEUR, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service d'oncologie médicale, Centre Hospitalier Universitaire de Grenbole</name>
      <address>
        <city>La Tronche</city>
        <zip>38700</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hervé CURE, MD</last_name>
      <email>hcure@chu-grenoble.fr</email>
    </contact>
    <investigator>
      <last_name>Hervé CURE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service de Médecine du vieillissement, Hôpital Edouard Herriot, HCL</name>
      <address>
        <city>Lyon</city>
        <zip>69003</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Byeul-A KIM, MD</last_name>
      <email>byeul-a.kim@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Elisabeth CASTEL-KREMER, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Catherine LOMBARD-BOHAS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas WALTER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Byeul-A KIM, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service de médecine du vieillissement, Hôpital de la Croix-Rousse, HCL</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amandine BRUYAS, MD</last_name>
      <email>amandine.bruyas@chu-lyon.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Service d'oncologie médicale, Cnetre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69373 cedex 08</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier TREDAN, MD</last_name>
      <email>olivier.tredan@lyon.unicancer.fr</email>
    </contact>
    <investigator>
      <last_name>Olivier TREDAN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service d'oncologie, Centre Hospitalier Annecy Genevois</name>
      <address>
        <city>Metz-Tessy</city>
        <zip>74370</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laëtitia STEFANI, MD</last_name>
      <email>lstefani@ch-annecygenevois.fr</email>
    </contact>
    <investigator>
      <last_name>Laëtitia STEFANI, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Service de Médecine du vieillissement, Centre Hospitalier Lyon Sud (Hospices Civils de Lyon)</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivia LE SAUX</last_name>
      <email>olivia.lesaux@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Claire FALANDRY, MD</last_name>
      <email>claire.falandry@chu-lyon.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Claire FALANDRY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Benoît YOU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Denis MAILLET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nathalie BONNIN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Véronique TRILLET-LENOIR, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Salima HAMIZI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sophie TARTAS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julien PERON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gilles FREYER, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Stéphane DALLE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Phelip GILDAS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre-Jean SOUQUET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>service de gériatrie, Hôpital de la Charité, Centre Hospitalier Universitaire de St-Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <zip>42100</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ana-Maria DASCALITA, MD</last_name>
    </contact>
    <contact_backup>
      <last_name>a.maria.dascalita@chu-st-etienne.fr</last_name>
    </contact_backup>
    <investigator>
      <last_name>Ana-MAria DASCALITA, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 23, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>May 12, 2023</last_update_submitted>
  <last_update_submitted_qc>May 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>therapeutic educational program</keyword>
  <keyword>adherence</keyword>
  <keyword>quality of life</keyword>
  <keyword>elderly</keyword>
  <keyword>cancer</keyword>
  <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/NCT03296150
org study id: 69HCL16_0149
nct id: NCT03296150
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
As the proportion of oral anticancer treatments is continuously increasing, adherence appears
      as a major issue for patients' outcomes. Poor adherence affects particularly geriatric
      patients due among others to polypharmacy or cognitive impairment. Thus, the need for
      educational programs in this population has been regularly emphasized.

      PRESTAGE educational program was built after an external and internal analysis of educational
      needs in elderly patients treated with oral cancer treatments. It implicates a
      multidisciplinary educational team (nurses, physicians, pharmacists, psychologists,
      physiologists, social workers...). Six educational workshops were designed with the following
      endpoints: disease and treatment understanding, treatment management, nutrition and
      psychological as well as physical well being.

      ADOPT-PRESTAGE is a clinical, prospective, interventional, open-label, multicenter,
      randomized, controlled trial designed to evaluate the impact of PRESTAGE program. It is, to
      the investigators' knowledge, the first randomized controlled trial evaluating the
      acceptability and impact (adherence, clinical benefit) of an educational program in an
      elderly cancer population. The primary endpoint of this trial will be to evaluate adherence
      using an indirect objective adherence measure: the Medication Event Monitoring System (MEMS).
      Secondary endpoints include quality of life and evaluation of changes in patients' behaviors.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Adherence evaluated by MicroElectronic Monitoring System
time frame: at 4 months (after intervention or information)
description: Adherence will be evaluated with MicroElectronic Monitoring System. A composite score such as described by Thivat et al. in 2013 will be used.
measure: Adherence evaluated by Morisky questionnaires
time frame: 4 months to 12 months
description: Results to Morisky questionnaires will be evaluated such as adherence with MEMS, until 12 months.
measure: Adherence evaluated by pharmacy medication refill -based adherence
time frame: 4 months to 12 months
description: Results to pharmacy medication refill -based adherence will be evaluated such as adherence with MEMS, until 12 months.
measure: Health-related quality of life evaluated by QLQ-C30 quality of life questionnaire
time frame: 4 months to 12 months
measure: Health-related quality of life evaluated by the QLQ-ELD14 quality of life questionnaire
time frame: 4 months to 12 months
measure: Health-related quality of life evaluated by the EORTC quality of life questionnaire
time frame: 4 months to 12 months
measure: Changes in patients' behaviors evaluated by questionnaires
time frame: 4 months to 12 months
description: Beliefs about Medication questionnaire and satisfaction with medication questionnaires
arm group label: Control arm : Information
arm group type: No Intervention
description: Patients will receive the usual standard information delivered to patients
arm group label: Intervention arm : Therapeutic educational program
arm group type: Experimental
description: Patients will receive the therapeutic educational program "PRESTAGE"
intervention type: Behavioral
intervention name: PRESTAGE
description: PRESTAGE educational program targets the acquisition by the patients and their caregivers of competencies in (1) a better understanding of their disease and (2) their treatment, (3) a better drug management, including both anticancer and supportive treatments, (4) maintenance of a good nutritional status, (5) general health and psychological well being and (6) physical well being. After an individual educational diagnosis, each patient will be proposed an individualized educational program consisting in 1 to 6 of these workshops. An individualized final interview - entitled educational synthesis - will assess patient's skills and satisfaction.
arm group label: Intervention arm : Therapeutic educational program
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Olivia LE SAUX
role: Study Chair
affiliation: Hospices Civils de Lyon
last name: Olivia LE SAUX
phone: 04 78 86 37 75
phone ext: +33
email: olivia.lesaux@gmail.com
last name: Claire FALANDRY, MD
phone: 04 78 86 15 80
phone ext: +33
email: claire.falandry@chu-lyon.fr
facility: 
status: Recruiting
contact: 
investigator: 
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: France
responsible party type: Sponsor
sharing ipd: No