<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/NCT02247583</url>
  </required_header>
  <id_info>
    <org_study_id>VF/2010/03</org_study_id>
    <secondary_id>s52586</secondary_id>
    <nct_id>NCT02247583</nct_id>
  </id_info>
  <brief_title>Investigating Patient Satisfaction With Oral Anti-Cancer Treatment</brief_title>
  <acronym>IPSOC</acronym>
  <official_title>Investigating Patient Satisfaction With Oral Anti-Cancer Treatment. Prospective Non-interventional Non-controlled Multicenter Observational Study to Evaluate Aspects of Pharmaceutical Care in Patients With Advanced Renal Cell Carcinoma Treated With an Oral Anti-cancer Drug.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Flemish League Against Cancer</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective non-interventional non-controlled multicenter observational study to evaluate&#xD;
      aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an&#xD;
      oral anti-cancer drug.&#xD;
&#xD;
      The main objective of this study is to evaluate the patient perspective in the treatment of&#xD;
      advanced renal cell carcinoma with an oral anti-cancer drug.&#xD;
&#xD;
      The following aspects will be investigated:&#xD;
&#xD;
        -  Intrinsic desire for information about treatment.&#xD;
&#xD;
        -  Patient satisfaction with treatment information.&#xD;
&#xD;
        -  Patient satisfaction with treatment.&#xD;
&#xD;
        -  Medication adherence.&#xD;
&#xD;
        -  Health-related quality of life.&#xD;
&#xD;
        -  The role of different health care professionals in the treatment of RCC with oral drugs&#xD;
&#xD;
      This study should reveal information necessary for the development of pharmacotherapeutic&#xD;
      care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug&#xD;
      over a long period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">July 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>one year</time_frame>
    <description>At the first visit patients will receive their anti-cancer medication by the hospital in a pill box which electronically records openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in this chip will be read in the hospital pharmacy each time the patient gets new capsules. This information is strictly confidential and can only be consulted by the research team at the KULeuven.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extent of Information Desire (EID)</measure>
    <time_frame>one year</time_frame>
    <description>Extent of information desire will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)</measure>
    <time_frame>one year</time_frame>
    <description>Satisfaction with cancer treatment information will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morisky Medication Adherence Scale (MMAS)</measure>
    <time_frame>one year</time_frame>
    <description>Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Therapy Satisfaction Questionnaire (CTSQ)</measure>
    <time_frame>one year</time_frame>
    <description>Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Cancer Therapy - General (FACT-G)</measure>
    <time_frame>one year</time_frame>
    <description>Health-related quality of life will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Kidney Symptom Index (FKSI)</measure>
    <time_frame>one year</time_frame>
    <description>Health-related quality of life will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Pharmacist (SwiP)</measure>
    <time_frame>one year</time_frame>
    <description>Satisfaction with the pharmacist will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Clear Cell Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>mRCC patients</arm_group_label>
    <description>Patients with metastatic renal cell carcinoma</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        mRCC patients starting with an oral anti-cancer treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are 18 years or older, and who can be contacted by phone and/or e-mail&#xD;
             are eligible for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are not able to understand Dutch or French will be excluded from the&#xD;
             study&#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>Veerle Foulon, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>September 19, 2014</last_update_submitted>
  <last_update_submitted_qc>September 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 25, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Sandra De Coster</investigator_full_name>
    <investigator_title>Pharmacist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Renal Cell</mesh_term>
  </condition_browse>
  <!-- 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/NCT02247583
org study id: VF/2010/03
secondary id: s52586
nct id: NCT02247583
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Prospective non-interventional non-controlled multicenter observational study to evaluate
      aspects of pharmaceutical care in patients with advanced renal cell carcinoma treated with an
      oral anti-cancer drug.

      The main objective of this study is to evaluate the patient perspective in the treatment of
      advanced renal cell carcinoma with an oral anti-cancer drug.

      The following aspects will be investigated:

        -  Intrinsic desire for information about treatment.

        -  Patient satisfaction with treatment information.

        -  Patient satisfaction with treatment.

        -  Medication adherence.

        -  Health-related quality of life.

        -  The role of different health care professionals in the treatment of RCC with oral drugs

      This study should reveal information necessary for the development of pharmacotherapeutic
      care concepts that meet the needs of cancer patients treated with an oral anti-cancer drug
      over a long period.
observational model: Cohort
time perspective: Prospective
measure: Medication adherence
time frame: one year
description: At the first visit patients will receive their anti-cancer medication by the hospital in a pill box which electronically records openings cf. Medication Event Monitoring System (MEMS®, Aardex). The recorded information in this chip will be read in the hospital pharmacy each time the patient gets new capsules. This information is strictly confidential and can only be consulted by the research team at the KULeuven.
measure: Extent of Information Desire (EID)
time frame: one year
description: Extent of information desire will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
measure: Patient Satisfaction with Cancer Treatment Education (Ps-CaTE)
time frame: one year
description: Satisfaction with cancer treatment information will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
measure: Morisky Medication Adherence Scale (MMAS)
time frame: one year
description: Medication adherence will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
measure: Cancer Therapy Satisfaction Questionnaire (CTSQ)
time frame: one year
description: Satisfaction with cancer treatment will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
time frame: one year
description: Health-related quality of life will be assessed, using a standardised questionnaire, at the start of the treatment, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
measure: Functional Kidney Symptom Index (FKSI)
time frame: one year
description: Health-related quality of life will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
measure: Satisfaction With Pharmacist (SwiP)
time frame: one year
description: Satisfaction with the pharmacist will be assessed, using a standardised questionnaire, after approximately 1, 3 and 6 months of treatment and after about 12 months, at discontinuation of therapy or at end of study (whatever is earlier).
arm group label: mRCC patients
description: Patients with metastatic renal cell carcinoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Veerle Foulon, Professor
role: Study Director
affiliation: Katholieke Universiteit Leuven - Klinische Farmacologie en Farmacotherapie
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Sandra De Coster
investigator title: Pharmacist
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell