<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/NCT03300310</url>
  </required_header>
  <id_info>
    <org_study_id>RC17_0096</org_study_id>
    <secondary_id>2017-A00629-44</secondary_id>
    <nct_id>NCT03300310</nct_id>
  </id_info>
  <brief_title>Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment in the Elderly</brief_title>
  <acronym>IPIO-PA</acronym>
  <official_title>Impact of the Nurse Visit on Observance of the Intake of Oral Carcinological Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</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>
      The increasingly used oral anticancer treatments allow the patient to reduce treatment and&#xD;
      social constraints to reduce hospitalization costs. The counterpart is a decrease in the&#xD;
      monitoring of the correct intake of drugs and the detection of side effects. These two risks&#xD;
      are major in the elderly, due to comorbidities, poly-medication and decreased attention. The&#xD;
      project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes&#xD;
      for 3 months, compared to a conventional management without a nursing visit. It is a&#xD;
      prospective, randomized, controlled, multicenter study to include 224 patients over 18&#xD;
      months. The impact will be assessed by counting the tablets not taken and by filling an&#xD;
      observation booklet with the nurse at home.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Anticipated">July 2019</completion_date>
  <primary_completion_date type="Anticipated">July 2019</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>Comparison, at 3 months after the oncological treatments began, of the observance rate of the anticancer drugs (corresponding to the entire carcinological protocol) with or without passage of a nurse at the patient's home.</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the patient's perception of observance to anticancer therapy</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of causes of possible premature and definitive cessation of cancer treatments 3 months after the start of treatment and changes in treatment (dose, rhythm of cycles)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patients' satisfaction (of the arm with passage of the nurse) and the professionals</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of the percentage of patients able to be included in the study compared to the number of patients who received an oncogeriatric assessment</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>Oncology, Gerontology</condition>
  <arm_group>
    <arm_group_label>with nursing visit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>a nurse visit is scheduled twice a week during 3 months at patient home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>without nursing visit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>no nursing visit</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nursing visit</intervention_name>
    <description>nursing visit at patient home</description>
    <arm_group_label>with nursing visit</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no nursing visit</intervention_name>
    <description>the patient take his treatment without nursing visit</description>
    <arm_group_label>without nursing visit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 70 and over&#xD;
&#xD;
          -  Patient initiating an oral anticancer treatment (Chemotherapy, Targeted therapy, 2nd&#xD;
             generation hormone therapy type Acetate abiraterone and Enzalutamide)&#xD;
&#xD;
          -  Patient who received an onco-geriatric assessment&#xD;
&#xD;
          -  Patient with informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient in a medical institution&#xD;
&#xD;
          -  Patient under exclusive hormone therapy&#xD;
&#xD;
          -  Patient already eligible for nurse support&#xD;
&#xD;
          -  Patient not speaking French&#xD;
&#xD;
          -  Patient under tutelage and guardianship or under safeguard of justice&#xD;
&#xD;
          -  Patient already included in a research protocol&#xD;
&#xD;
          -  Patient sharing his or her home with a person receiving nursing care at home more than&#xD;
             once a week and for a period longer than 1 month after the patient's inclusion.&#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_contact>
    <last_name>Laure De Decker, Pr</last_name>
    <phone>+33 2 40 16 50 54</phone>
    <email>Laure.dedecker@chu-nantes.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>ICO Angers</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Benedicte DAillieres, Dr</last_name>
      <email>Benedicte.DAillieres@ico.unicancer.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche-sur-Yon</city>
        <zip>85000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Martine Martin-Grellier, Dr</last_name>
      <email>martine.martin@chd-vendee.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Laure De Decker, Pr</last_name>
      <email>Laure.dedecker@chu-nantes.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital privé du Confluent</name>
      <address>
        <city>Nantes</city>
        <zip>44200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Aude Bezier, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Saint Nazaire</name>
      <address>
        <city>Saint Nazaire</city>
        <zip>44 606</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne Lebatard-Sartre, Dr</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>ICO Nantes</name>
      <address>
        <city>St Herblain</city>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Emmanuelle Bourbouloux, Dr</last_name>
      <email>Emmanuelle.bourbouloux@ico.unicancer.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>December 5, 2017</last_update_submitted>
  <last_update_submitted_qc>December 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</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/NCT03300310
org study id: RC17_0096
secondary id: 2017-A00629-44
nct id: NCT03300310
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The increasingly used oral anticancer treatments allow the patient to reduce treatment and
      social constraints to reduce hospitalization costs. The counterpart is a decrease in the
      monitoring of the correct intake of drugs and the detection of side effects. These two risks
      are major in the elderly, due to comorbidities, poly-medication and decreased attention. The
      project objective to evaluate the impact of a bi-weekly nursing visit to the patients' homes
      for 3 months, compared to a conventional management without a nursing visit. It is a
      prospective, randomized, controlled, multicenter study to include 224 patients over 18
      months. The impact will be assessed by counting the tablets not taken and by filling an
      observation booklet with the nurse at home.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Comparison, at 3 months after the oncological treatments began, of the observance rate of the anticancer drugs (corresponding to the entire carcinological protocol) with or without passage of a nurse at the patient's home.
time frame: 3 months
measure: Comparison of the patient's perception of observance to anticancer therapy
time frame: 3 months
measure: Comparison of causes of possible premature and definitive cessation of cancer treatments 3 months after the start of treatment and changes in treatment (dose, rhythm of cycles)
time frame: 3 months
measure: Assessment of patients' satisfaction (of the arm with passage of the nurse) and the professionals
time frame: 3 months
measure: Determination of the percentage of patients able to be included in the study compared to the number of patients who received an oncogeriatric assessment
time frame: 3 months
arm group label: with nursing visit
arm group type: Experimental
description: a nurse visit is scheduled twice a week during 3 months at patient home.
arm group label: without nursing visit
arm group type: Experimental
description: no nursing visit
intervention type: Other
intervention name: nursing visit
description: nursing visit at patient home
arm group label: with nursing visit
intervention type: Other
intervention name: no nursing visit
description: the patient take his treatment without nursing visit
arm group label: without nursing visit
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Laure De Decker, Pr
phone: +33 2 40 16 50 54
email: Laure.dedecker@chu-nantes.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Neoplasms
sharing ipd: No