<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/NCT03257969</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0029</org_study_id>
    <nct_id>NCT03257969</nct_id>
  </id_info>
  <brief_title>Impact of the DROP Program on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors</brief_title>
  <acronym>DROP-SFPO</acronym>
  <official_title>Impact of the DROP (Drug Related Problems in Oncology Practice) Program of Pharmaceutical Interventions of the French Society of Oncological Pharmacology Versus Usual Care on the DRP (Drug Related Problems) Related to Oral Anticancer Drugs in Ambulatory Patients With Risk Factors</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>
    <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 rise of oral anticancer drugs favors outpatient care but exposes patients to new risks&#xD;
      compared to injectable chemotherapy at hospital: non-adherence to treatment, inappropriate&#xD;
      management of side effects and interactions with other co-prescribed drugs. Latrogenic risk&#xD;
      of these treatments is reinforced in older patients with frequent comorbidities, taking&#xD;
      multiple pharmaceutical treatments for long periods and followed by several prescribers.&#xD;
&#xD;
      The literature reports an emergence of drug related problems (DRP) in more than 90% of&#xD;
      patients, with an average number of 0 to 4 per patient. The clinical consequences (reduced&#xD;
      efficacy and potentiation of toxicity) are all the more important that outpatient monitoring&#xD;
      of treatments prescribed at the hospital remains underdeveloped due to default of&#xD;
      coordination between these two settings.&#xD;
&#xD;
      Medical care and prevention of these DRP are difficult because of a lack of information and&#xD;
      tools shared between hospital and liberal actors. Experiments are developed according to&#xD;
      different organizational models, frequently focused on the pharmaceutical analysis of&#xD;
      prescriptions, the detection of DRP and their control, but they stay still undervalued. In&#xD;
      this context, the French Society of Oncological Pharmacology (SFPO - Société Française de&#xD;
      Pharmacie Oncologique) provides to hospital and ambulatory care pharmacists the Oncolien&#xD;
      website and proposes to assess the impact of a program of pharmaceutical interventions named&#xD;
      DROP. The hypothesis of the study is that the DROP program will secure the medical care of&#xD;
      patients with oral anticancer drugs compared to the usual care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 18, 2019</start_date>
  <completion_date type="Anticipated">March 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</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>Number of DRP (Drug Relates Problems) related to oral anticancer drugs per patient, in total and for each category</measure>
    <time_frame>9 months post-inclusion</time_frame>
    <description>DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total number of DRP related to all prescribed drugs per patient</measure>
    <time_frame>6 months and 9 months post-inclusion</time_frame>
    <description>DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient</measure>
    <time_frame>6 months and 9 months post-inclusion</time_frame>
    <description>dose adjustments, cure spacing, interruptions and cessation of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative dose intensity of the oral anticancer drug</measure>
    <time_frame>6 months post-inclusion</time_frame>
    <description>Relative dose intensity will be computed by the ratio between the overall dose prescribed during the 6 months of follow-up and the theoretical dosage according to the summary of product characteristics of the market authorization.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to the oral anticancer drug</measure>
    <time_frame>6 months post-inclusion</time_frame>
    <description>Adherence will be measured with the Girerd questionnaire score 6 items from the Ameli Health Insurance website and the rate of prescription renewal by the ambulatory pharmacy (adherence will be defined as a rate ≥80%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of imaging acts and nature of acts</measure>
    <time_frame>During the 6 months of follow-up</time_frame>
    <description>To evaluate consumption of unscheduled ambulatory care related to DRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of acts of biology and nature of acts</measure>
    <time_frame>During the 6 months of follow-up</time_frame>
    <description>To evaluate consumption of unscheduled ambulatory care related to DRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of medical consultations</measure>
    <time_frame>During the 6 months of follow-up</time_frame>
    <description>To evaluate consumption of unscheduled ambulatory care related to DRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of prescriptions of drugs (without prescription of the oral anticancer drug) and nature of these drugs</measure>
    <time_frame>During the 6 months of follow-up</time_frame>
    <description>To evaluate consumption of unscheduled ambulatory care related to DRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions</measure>
    <time_frame>During the 6 months of follow-up</time_frame>
    <description>To evaluate unplanned hospital admissions related to DRP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire</measure>
    <time_frame>At inclusion and 6 months from the treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire</measure>
    <time_frame>At inclusion and 6 months from the treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale</measure>
    <time_frame>At inclusion and 6 months from the treatment initiation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of interventions of primary care actors with the patient</measure>
    <time_frame>During the 9 months of follow-up</time_frame>
    <description>To evaluate the involvement of primary care actors in the DROP program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of time the Oncolien website was used by ambulatory care pharmacists</measure>
    <time_frame>During the 9 months of follow-up</time_frame>
    <description>To evaluate the involvement of primary care actors in the DROP program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of forms helping the delivery of the oral anticancer drug used by ambulatory care pharmacists</measure>
    <time_frame>During the 9 months of follow-up</time_frame>
    <description>To evaluate the involvement of primary care actors in the DROP program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient-advice forms downloaded and delivered to the patient</measure>
    <time_frame>During the 9 months of follow-up</time_frame>
    <description>To evaluate the involvement of primary care actors in the DROP program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and reason for solicitations of hospital actors by the primary care actors, in the context of information sharing</measure>
    <time_frame>During the 9 months of follow-up</time_frame>
    <description>To evaluate the involvement of primary care actors in the DROP program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction for the DROP program</measure>
    <time_frame>At 9 months post-inclusion</time_frame>
    <description>Satisfaction will be measured with a 10-point visual analog scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ambulatory care physician's and pharmacist's satisfactions with the DROP program</measure>
    <time_frame>At 9 months post-inclusion</time_frame>
    <description>Satisfaction will be measured with a 10-point visual analog scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficiency of the DROP program</measure>
    <time_frame>9 months post-inclusion</time_frame>
    <description>Efficiency will be computed by the incremental cost-efficacy ratio between the DROP program and the usual care.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">248</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>The DROP program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The DROP program of pharmaceutical interventions</intervention_name>
    <description>Multidisciplinary program that includes informative sessions with a hospital pharmacist about the oral anticancer drug: information is given to the patient on adverse events occurrence and there management; and optimizing drug dosage plan, including drug-drug interactions.</description>
    <arm_group_label>The DROP program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>In the group with standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessment.</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 18 years old or more&#xD;
&#xD;
          -  With cancer&#xD;
&#xD;
          -  For wich the initiation or change of an oral anticancer drug is prescribed&#xD;
&#xD;
          -  With life expectancy estimated to be 6 months or more, in the opinion of the&#xD;
             investigator&#xD;
&#xD;
          -  Of which the treatment with oral anticancer medication is estimated to be 6 months or&#xD;
             more in the opinion of the oncologist&#xD;
&#xD;
          -  Benefiting from an initiation or a change of oral anticancer agents according to the&#xD;
             MA: cytotoxic agent, targeted therapy, hormonal therapy (excluding adjuvant&#xD;
             treatments);&#xD;
&#xD;
          -  of which the oral anticancer drug is delivered in pharmacy of town or in retrocession&#xD;
             hospital;&#xD;
&#xD;
          -  With ambulatory status (not hospitalized for the management and treatment )&#xD;
&#xD;
          -  Taking 5 or more drugs, including the oral anticancer treatment, and / or treated with&#xD;
             an oral anticancer drug requiring complex regimen (combination of 2 oral anticancer&#xD;
             drugs, or sequential rate of intake, or associated to intravenous chemotherapy)&#xD;
&#xD;
          -  With a sufficient autonomy for the management of medication at home&#xD;
&#xD;
          -  Without either cognitive disorders or major psychiatric disorders, in the opinion of&#xD;
             the investigator&#xD;
&#xD;
          -  Ability to read, write and understand the French language&#xD;
&#xD;
          -  Having given his written consent to participate in the study&#xD;
&#xD;
          -  Patient affiliated to the social security scheme or equivalent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
&#xD;
          -  Patient on anti-PD1, anti-PDL-1 or anti-CTLA4-4 immunotherapy concomitant with oral&#xD;
             anticancer treatment&#xD;
&#xD;
          -  Patient under radiotherapy concomitant treatment with oral anticancer&#xD;
&#xD;
          -  Oral anticancer agent prescribed in a delivery circuit as part of an ATU or clinical&#xD;
             trial;&#xD;
&#xD;
          -  Patient with significant cognitive or psychiatric disorders, in the opinion of the&#xD;
             investigator;&#xD;
&#xD;
          -  Management of drug treatment at home is performed exclusively by the caregiver;&#xD;
&#xD;
          -  Not having declared a doctor;&#xD;
&#xD;
          -  Not having a usual city pharmacy, or reporting 2 or more usual city pharmacies;&#xD;
&#xD;
          -  Patient who has already benefited from a therapeutic education program&#xD;
&#xD;
          -  In institution or guardianship, major protected by the 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_contact>
    <last_name>Catherine RIOUFOL, PharmD</last_name>
    <phone>04 78 86 43 70</phone>
    <phone_ext>+33</phone_ext>
    <email>catherine.rioufol@chu-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laure HUOT, PharmD</last_name>
    <phone>04 72 11 57 62</phone>
    <phone_ext>+33</phone_ext>
    <email>laure.huot@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Service pharmaceutique, Unité de Pharmacie Clinique Oncologique, Centre Hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <zip>69310</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Catherine RIOUFOL, PharmD</last_name>
      <phone>04 78 86 43 70</phone>
      <phone_ext>+33</phone_ext>
      <email>catherine.rioufol@chu-lyon.fr</email>
    </contact>
    <contact_backup>
      <last_name>Laure HUOT, PharmD</last_name>
      <phone>04 72 11 57 62</phone>
      <phone_ext>+33</phone_ext>
      <email>laure.huot@chu-lyon.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 28, 2021</last_update_submitted>
  <last_update_submitted_qc>October 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oral chemotherapy</keyword>
  <keyword>Health related program</keyword>
  <keyword>Secured drug intake</keyword>
  <keyword>Pharmacist intervention</keyword>
  <keyword>Cancer outpatient</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/NCT03257969
org study id: 69HCL17_0029
nct id: NCT03257969
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The rise of oral anticancer drugs favors outpatient care but exposes patients to new risks
      compared to injectable chemotherapy at hospital: non-adherence to treatment, inappropriate
      management of side effects and interactions with other co-prescribed drugs. Latrogenic risk
      of these treatments is reinforced in older patients with frequent comorbidities, taking
      multiple pharmaceutical treatments for long periods and followed by several prescribers.

      The literature reports an emergence of drug related problems (DRP) in more than 90% of
      patients, with an average number of 0 to 4 per patient. The clinical consequences (reduced
      efficacy and potentiation of toxicity) are all the more important that outpatient monitoring
      of treatments prescribed at the hospital remains underdeveloped due to default of
      coordination between these two settings.

      Medical care and prevention of these DRP are difficult because of a lack of information and
      tools shared between hospital and liberal actors. Experiments are developed according to
      different organizational models, frequently focused on the pharmaceutical analysis of
      prescriptions, the detection of DRP and their control, but they stay still undervalued. In
      this context, the French Society of Oncological Pharmacology (SFPO - Société Française de
      Pharmacie Oncologique) provides to hospital and ambulatory care pharmacists the Oncolien
      website and proposes to assess the impact of a program of pharmaceutical interventions named
      DROP. The hypothesis of the study is that the DROP program will secure the medical care of
      patients with oral anticancer drugs compared to the usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Number of DRP (Drug Relates Problems) related to oral anticancer drugs per patient, in total and for each category
time frame: 9 months post-inclusion
description: DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I).
measure: Total number of DRP related to all prescribed drugs per patient
time frame: 6 months and 9 months post-inclusion
description: DRP are defined as the number of: adverse reactions (grade 2-3-4); drug interactions (contraindication, association not recommended, precautionary use); and medication errors with proven harm or requiring appropriate monitoring (Medication Error Index of the National Coordinating Council for Medication Error Reporting and Prevention, grade D to I).
measure: Number of adaptations in the prescription of oral anticancer drugs, related to DRP, per patient
time frame: 6 months and 9 months post-inclusion
description: dose adjustments, cure spacing, interruptions and cessation of treatment.
measure: Relative dose intensity of the oral anticancer drug
time frame: 6 months post-inclusion
description: Relative dose intensity will be computed by the ratio between the overall dose prescribed during the 6 months of follow-up and the theoretical dosage according to the summary of product characteristics of the market authorization.
measure: Adherence to the oral anticancer drug
time frame: 6 months post-inclusion
description: Adherence will be measured with the Girerd questionnaire score 6 items from the Ameli Health Insurance website and the rate of prescription renewal by the ambulatory pharmacy (adherence will be defined as a rate ≥80%).
measure: Number of imaging acts and nature of acts
time frame: During the 6 months of follow-up
description: To evaluate consumption of unscheduled ambulatory care related to DRP
measure: Number of acts of biology and nature of acts
time frame: During the 6 months of follow-up
description: To evaluate consumption of unscheduled ambulatory care related to DRP
measure: Number of medical consultations
time frame: During the 6 months of follow-up
description: To evaluate consumption of unscheduled ambulatory care related to DRP
measure: Number of prescriptions of drugs (without prescription of the oral anticancer drug) and nature of these drugs
time frame: During the 6 months of follow-up
description: To evaluate consumption of unscheduled ambulatory care related to DRP
measure: Number of hospital admissions
time frame: During the 6 months of follow-up
description: To evaluate unplanned hospital admissions related to DRP
measure: Patient's quality of life, measured with the EuroQol 5-Dimensions questionnaire
time frame: At inclusion and 6 months from the treatment initiation
measure: Patient's satisfaction with treatment, measured with the SAT-MED Q questionnaire
time frame: At inclusion and 6 months from the treatment initiation
measure: Health locus of control, measured with the Therapeutic Self Care Toll (TSCT) scale
time frame: At inclusion and 6 months from the treatment initiation
measure: Number of interventions of primary care actors with the patient
time frame: During the 9 months of follow-up
description: To evaluate the involvement of primary care actors in the DROP program
measure: Number of time the Oncolien website was used by ambulatory care pharmacists
time frame: During the 9 months of follow-up
description: To evaluate the involvement of primary care actors in the DROP program
measure: Number of forms helping the delivery of the oral anticancer drug used by ambulatory care pharmacists
time frame: During the 9 months of follow-up
description: To evaluate the involvement of primary care actors in the DROP program
measure: Number of patient-advice forms downloaded and delivered to the patient
time frame: During the 9 months of follow-up
description: To evaluate the involvement of primary care actors in the DROP program
measure: Number and reason for solicitations of hospital actors by the primary care actors, in the context of information sharing
time frame: During the 9 months of follow-up
description: To evaluate the involvement of primary care actors in the DROP program
measure: Patient's satisfaction for the DROP program
time frame: At 9 months post-inclusion
description: Satisfaction will be measured with a 10-point visual analog scale.
measure: Ambulatory care physician's and pharmacist's satisfactions with the DROP program
time frame: At 9 months post-inclusion
description: Satisfaction will be measured with a 10-point visual analog scale.
measure: Efficiency of the DROP program
time frame: 9 months post-inclusion
description: Efficiency will be computed by the incremental cost-efficacy ratio between the DROP program and the usual care.
arm group label: The DROP program
arm group type: Experimental
arm group label: Standard of care
arm group type: Other
intervention type: Behavioral
intervention name: The DROP program of pharmaceutical interventions
description: Multidisciplinary program that includes informative sessions with a hospital pharmacist about the oral anticancer drug: information is given to the patient on adverse events occurrence and there management; and optimizing drug dosage plan, including drug-drug interactions.
arm group label: The DROP program
intervention type: Behavioral
intervention name: Standard of care
description: In the group with standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessment.
arm group label: Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine RIOUFOL, PharmD
phone: 04 78 86 43 70
phone ext: +33
email: catherine.rioufol@chu-lyon.fr
last name: Laure HUOT, PharmD
phone: 04 72 11 57 62
phone ext: +33
email: laure.huot@chu-lyon.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
sharing ipd: No