<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/NCT03275675</url>
  </required_header>
  <id_info>
    <org_study_id>CHU-344</org_study_id>
    <secondary_id>2017-A01139-44</secondary_id>
    <nct_id>NCT03275675</nct_id>
  </id_info>
  <brief_title>Evaluation of Patients' Satisfaction With the Dispensation of Their Oral Anticancer Treatment in Community Pharmacy</brief_title>
  <acronym>ORCA</acronym>
  <official_title>Evaluation of Patients' Satisfaction With the Dispensation of Their Oral Anticancer Treatment in Community Pharmacy: Observational and Transversal Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      The pharmacist, as a specialist of medications, occupies a strategic position: he&#xD;
      participates in a global care of their patients. Dispensation is the pharmaceutical act which&#xD;
      associates with the dispensing of medications &quot;the pharmaceutical analysis of the medical&#xD;
      prescription if it exists, the possible preparation of the doses to be administered and the&#xD;
      provisions of the information and advices necessary for the proper use of medications&quot;. The&#xD;
      pharmacist ensures that the quality and safety of the dispensation is guaranteed at all times&#xD;
      by limiting as far as possible the risks associated with an error in delivery, prescription,&#xD;
      drug interactions or undetected contraindications, inadequate dosages or non-compliance with&#xD;
      treatment. The longer the patient feels satisfied with the stage of delivery of his&#xD;
      treatment, the better his adherence to treatment is, and the less he will encounter poor&#xD;
      compliance. Oncology has particularly benefited in recent years from the introduction of&#xD;
      numerous drugs with the aim of extending the duration of response in a growing number of&#xD;
      indications. Traditionally in oncology, chemotherapy treatments are administered&#xD;
      intravenously by trained personnel and rarely managed by the patient at home. Recently, there&#xD;
      has been a growing choice of oral formulations, whether for conventional hormonal, anticancer&#xD;
      therapies or targeted therapies. These specialties are now widely available in community&#xD;
      pharmacies. Oral administration puts the patient at the center of his therapeutic management.&#xD;
      He must take his medication alone. Adherence and compliance are therefore particularly&#xD;
      important here for an optimal risk-benefit ratio. This study project is designed to evaluate&#xD;
      the satisfaction of patients undergoing oral chemotherapy treated for a cancer pathology and&#xD;
      whose treatment is provided by their community pharmacies. It also needs to provide&#xD;
      information about the reasons for their poor adherence to treatment (personal factors,&#xD;
      factors attributable to treatment, factors attributable to the care system). Patients will be&#xD;
      recruited and interviewed by contacting several departments of the Clermont-Ferrand&#xD;
      University Hospital (CHU de Clermont-Ferrand), who are used to caring for patients with&#xD;
      cancerous diseases (hematology, urology, respiratory, gastro-enterology). The data collected&#xD;
      in this study may be used for subsequent studies evaluating new management strategies or&#xD;
      therapeutic education to improve adherence to patient treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This observational and transversal study will be conducted as a survey by contacting each&#xD;
      eligible patients after complete information by the oncologist. After acceptance, the&#xD;
      patients will received a postal mail with the questionnaire and a stamped envelope for the&#xD;
      return of completed questionnaire. All the completed questionnaires will be recorded in a&#xD;
      specific REDCap database for analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2017</start_date>
  <completion_date type="Actual">April 11, 2019</completion_date>
  <primary_completion_date type="Actual">April 11, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of patients' satisfaction with the dispensation of their oral anticancer treatments in community pharmacy</measure>
    <time_frame>at day 1</time_frame>
    <description>(visual analogic scale 0-100)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of patients' satisfaction based on Quality of Information Provided by Oncologists and Pharmacists</measure>
    <time_frame>at day 1</time_frame>
    <description>(visual analogic scale 0-100)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patients' satisfaction based on type of cancer</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patients' satisfaction based on type of treatment received</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patients' satisfaction based on number of medications taken per day</measure>
    <time_frame>at day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of patients' satisfaction based on patient characteristics</measure>
    <time_frame>at day 1</time_frame>
    <description>age, gender, professional status, marital status, level of study</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">104</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Patients with cancer chemotherapy</arm_group_label>
    <description>This study project is designed to evaluate the satisfaction of patients undergoing oral chemotherapy treated for a cancer and whose treatment is provided by their community pharmacies.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Oral anticancer medications</intervention_name>
    <description>All the oral medications for cancer treatment (hormonal, cytotoxic and targeted therapies)</description>
    <arm_group_label>Patients with cancer chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study project is designed to evaluate the satisfaction of patients undergoing oral&#xD;
        chemotherapy treated for a cancer pathology and whose treatment is provided by their&#xD;
        community pharmacies. It also needs to provide information about the reasons for their poor&#xD;
        adherence to treatment (personal factors, factors attributable to treatment, factors&#xD;
        attributable to the care system).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient (or helping people) receiving oral cancer chemotherapy or oral hormone therapy&#xD;
             delivered in community pharmacy for the treatment of cancer&#xD;
&#xD;
          -  Non-opposition to participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient unable to understand or respond to questionnaires&#xD;
&#xD;
          -  Age &lt; 18&#xD;
&#xD;
          -  Legal incapacity (person deprived of liberty or under guardianship)&#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>David BALAYSSAC, PhD, PharmD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Clermont-Ferrand</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <state>Auvergne</state>
        <zip>63003</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>June 3, 2022</last_update_submitted>
  <last_update_submitted_qc>June 3, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Oral chemotherapy</keyword>
  <keyword>Community Pharmacy</keyword>
  <keyword>Satisfaction</keyword>
  <!-- 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/NCT03275675
org study id: CHU-344
secondary id: 2017-A01139-44
nct id: NCT03275675
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The pharmacist, as a specialist of medications, occupies a strategic position: he
      participates in a global care of their patients. Dispensation is the pharmaceutical act which
      associates with the dispensing of medications "the pharmaceutical analysis of the medical
      prescription if it exists, the possible preparation of the doses to be administered and the
      provisions of the information and advices necessary for the proper use of medications". The
      pharmacist ensures that the quality and safety of the dispensation is guaranteed at all times
      by limiting as far as possible the risks associated with an error in delivery, prescription,
      drug interactions or undetected contraindications, inadequate dosages or non-compliance with
      treatment. The longer the patient feels satisfied with the stage of delivery of his
      treatment, the better his adherence to treatment is, and the less he will encounter poor
      compliance. Oncology has particularly benefited in recent years from the introduction of
      numerous drugs with the aim of extending the duration of response in a growing number of
      indications. Traditionally in oncology, chemotherapy treatments are administered
      intravenously by trained personnel and rarely managed by the patient at home. Recently, there
      has been a growing choice of oral formulations, whether for conventional hormonal, anticancer
      therapies or targeted therapies. These specialties are now widely available in community
      pharmacies. Oral administration puts the patient at the center of his therapeutic management.
      He must take his medication alone. Adherence and compliance are therefore particularly
      important here for an optimal risk-benefit ratio. This study project is designed to evaluate
      the satisfaction of patients undergoing oral chemotherapy treated for a cancer pathology and
      whose treatment is provided by their community pharmacies. It also needs to provide
      information about the reasons for their poor adherence to treatment (personal factors,
      factors attributable to treatment, factors attributable to the care system). Patients will be
      recruited and interviewed by contacting several departments of the Clermont-Ferrand
      University Hospital (CHU de Clermont-Ferrand), who are used to caring for patients with
      cancerous diseases (hematology, urology, respiratory, gastro-enterology). The data collected
      in this study may be used for subsequent studies evaluating new management strategies or
      therapeutic education to improve adherence to patient treatment.
This observational and transversal study will be conducted as a survey by contacting each
      eligible patients after complete information by the oncologist. After acceptance, the
      patients will received a postal mail with the questionnaire and a stamped envelope for the
      return of completed questionnaire. All the completed questionnaires will be recorded in a
      specific REDCap database for analysis.
observational model: Other
time perspective: Prospective
measure: Assessment of patients' satisfaction with the dispensation of their oral anticancer treatments in community pharmacy
time frame: at day 1
description: (visual analogic scale 0-100)
measure: Assessment of patients' satisfaction based on Quality of Information Provided by Oncologists and Pharmacists
time frame: at day 1
description: (visual analogic scale 0-100)
measure: Assessment of patients' satisfaction based on type of cancer
time frame: at day 1
measure: Assessment of patients' satisfaction based on type of treatment received
time frame: at day 1
measure: Assessment of patients' satisfaction based on number of medications taken per day
time frame: at day 1
measure: Assessment of patients' satisfaction based on patient characteristics
time frame: at day 1
description: age, gender, professional status, marital status, level of study
arm group label: Patients with cancer chemotherapy
description: This study project is designed to evaluate the satisfaction of patients undergoing oral chemotherapy treated for a cancer and whose treatment is provided by their community pharmacies.
intervention type: Drug
intervention name: Oral anticancer medications
description: All the oral medications for cancer treatment (hormonal, cytotoxic and targeted therapies)
arm group label: Patients with cancer chemotherapy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David BALAYSSAC, PhD, PharmD
role: Principal Investigator
affiliation: CHU de Clermont-Ferrand
facility: 
country: France
responsible party type: Sponsor