<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/NCT03263416</url>
  </required_header>
  <id_info>
    <org_study_id>17GENE02</org_study_id>
    <nct_id>NCT03263416</nct_id>
  </id_info>
  <brief_title>Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up Compared to Standard Follow-up.</brief_title>
  <acronym>ADHESIPH</acronym>
  <official_title>Regional, Multicentric, Randomized Study Evaluating Treatment Adherence in Patients Treated With Oral Targeted Therapy in Oncology Supported by a Dedicated and Coordinated Follow-up (Using a Telephone Follow-up by a Nurse and a Pharmaceutical Conciliation) Compared to Standard Follow-up.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Claudius Regaud</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Claudius Regaud</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>
      This is a prospective, comparative, open label, randomized, multicentric study evaluating the&#xD;
      benefit of a dedicated and coordinated follow-up on treatment adherence in patients with&#xD;
      metastatic solid tumor and starting a first cycle of treatment compared to standard&#xD;
      follow-up. A dedicated and coordinated follow-up during the treatment period will be based on&#xD;
      a telephone follow-up and a pharmaceutical conciliation.&#xD;
&#xD;
      Patients will be randomized into one of two study arms:&#xD;
&#xD;
      Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a&#xD;
      pharmaceutical conciliation made by the Center Pharmacist.&#xD;
&#xD;
      Arm B: Standard follow-up during the treatment period.&#xD;
&#xD;
      Patients will be followed during 6 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">January 25, 2022</completion_date>
  <primary_completion_date type="Actual">January 25, 2022</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.</measure>
    <time_frame>6 months per patient</time_frame>
    <description>This outcome will be assessed by the counting of tablets and the completion of the GIRERD questionnaire by the patient (assessment performed at 1, 3 and 6 months during the treatment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation</measure>
    <time_frame>6 months per patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life using the QLQ-C30 questionnaire</measure>
    <time_frame>6 months per patient</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03</measure>
    <time_frame>6 months per patient</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Metastatic Solid Tumor</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Standard</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dedicated and coordinated follow-up</intervention_name>
    <description>Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period&#xD;
Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist&#xD;
Completion of QLQ-C30 and GIRERD questionnaires</description>
    <arm_group_label>Arm A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard follow-up</intervention_name>
    <description>- Completion of QLQ-C30 and GIRERD questionnaires</description>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient with a metastatic solid tumor and starting a first cycle of oral targeted&#xD;
             therapy whatever the treatment line&#xD;
&#xD;
          2. Age &gt; or = 18 years old&#xD;
&#xD;
          3. Affiliated to the french social security system&#xD;
&#xD;
          4. Patient must provide written informed consent prior to any study-specific procedure or&#xD;
             assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient not available by phone or with no caregiver who can answer the phone for him&#xD;
&#xD;
          2. Pregnant or breastfeeding women&#xD;
&#xD;
          3. Any psychological, familial, geographic or social situation, according to the judgment&#xD;
             of investigator, potentially preventing the provision of informed consent or&#xD;
             compliance to study procedure&#xD;
&#xD;
          4. Patient protected by law&#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>Christine CHEVREAU, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Universitaire du Cancer Toulouse Oncopole</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique Claude Bernard</name>
      <address>
        <city>Albi</city>
        <zip>81000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal Castres Mazamet</name>
      <address>
        <city>Castres</city>
        <zip>81108</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Des Cedres</name>
      <address>
        <city>Cornebarrieu</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Claudius Regaud</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>January 28, 2022</last_update_submitted>
  <last_update_submitted_qc>January 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic solid tumor</keyword>
  <keyword>Oral Targeted Therapy</keyword>
  <keyword>Treatment adherence</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/NCT03263416
org study id: 17GENE02
nct id: NCT03263416
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective, comparative, open label, randomized, multicentric study evaluating the
      benefit of a dedicated and coordinated follow-up on treatment adherence in patients with
      metastatic solid tumor and starting a first cycle of treatment compared to standard
      follow-up. A dedicated and coordinated follow-up during the treatment period will be based on
      a telephone follow-up and a pharmaceutical conciliation.

      Patients will be randomized into one of two study arms:

      Arm A (Experimental follow-up): coordinated follow-up performed by a dedicated nurse and a
      pharmaceutical conciliation made by the Center Pharmacist.

      Arm B: Standard follow-up during the treatment period.

      Patients will be followed during 6 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Efficacy: rate of patients who adhere to oral targeted therapy treatment administration.
time frame: 6 months per patient
description: This outcome will be assessed by the counting of tablets and the completion of the GIRERD questionnaire by the patient (assessment performed at 1, 3 and 6 months during the treatment)
measure: Evaluation of the number of drug adaptations proposed by the Center Pharmacist following the pharmaceutical conciliation
time frame: 6 months per patient
measure: Quality of life using the QLQ-C30 questionnaire
time frame: 6 months per patient
measure: Safety according to the classification of the Common for Toxicity Criteria for Adverse Events (CTCAE) V4.03
time frame: 6 months per patient
arm group label: Arm A
arm group type: Experimental
arm group label: Arm B
arm group type: Other
description: Standard
intervention type: Other
intervention name: Dedicated and coordinated follow-up
description: Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period
Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist
Completion of QLQ-C30 and GIRERD questionnaires
arm group label: Arm A
intervention type: Other
intervention name: Standard follow-up
description: - Completion of QLQ-C30 and GIRERD questionnaires
arm group label: Arm B
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christine CHEVREAU, MD
role: Principal Investigator
affiliation: Institut Universitaire du Cancer Toulouse Oncopole
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No