<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/NCT02224768</url>
  </required_header>
  <id_info>
    <org_study_id>CA184-242</org_study_id>
    <nct_id>NCT02224768</nct_id>
  </id_info>
  <brief_title>YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey</brief_title>
  <official_title>YERVOY Risk Minimisation Tool Evaluation Survey</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in&#xD;
      terms of awareness about these tools, their utilization, knowledge and comprehension of&#xD;
      Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional&#xD;
      (HCP)s and patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total sample size of 160 to 200 HCPs and 160 to 200 patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of YERVOY HCPs that are aware of the existence of the risk communications tools and how the tools were accessed (i.e. paper or electronic versions)</measure>
    <time_frame>6 months</time_frame>
    <description>Distribution metrics and awareness of the tools from responses through the survey will be analysed and descriptive statistics will be used within the different participant groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Questionnaire: &quot;Who uses the RM communication tools, how, when they are used and how often they are used&quot;</measure>
    <time_frame>6 months</time_frame>
    <description>Web downloads metrics will be collected and the usage of tools from responses in the survey will be analysed, and descriptive statistics will be used within the participant groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of knowledge and comprehension of the key elements of important identified risks associated with YERVOY treatment based on the scores obtained from the Questionnaire Surveys</measure>
    <time_frame>6 months</time_frame>
    <description>Knowledge and comprehension in HCPs and patients, the knowledge surveys will provide the following data&#xD;
Total number of responses to the question including the proportions of correct answers to questions where appropriate&#xD;
Number or frequency and proportion of response options selected&#xD;
Percentage of responses/total responses per option&#xD;
Mean value and standard deviation (for appropriate questions)&#xD;
From the obtained data, Acceptable levels of correct responses will be determined, post data analysis, reporting and discussion with EMA, to set baseline levels for potential future evaluations and then the scores will be assessed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys</measure>
    <time_frame>6 months</time_frame>
    <description>For determining appropriate behaviours in HCPs and patients, ideal expected behaviours will be mapped to the ideal care pathway from the Failure Modes and Effects Analysis (FMEA) as described in the RMP. The metrics will show:&#xD;
Total of number of participants answering the question.&#xD;
Proportions of participants providing correct answers (to identify knowledge and comprehension)&#xD;
Proportion of participants showing expected (ideal) behaviour - i.e. correct answers to individual questions.&#xD;
Proportion of participants showing non-ideal behaviour - i.e. partially correct or incorrect answers to individual questions.&#xD;
Analysis will examine knowledge, comprehension and behaviours for different participant types (HCP, Hospital type and Country)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">158</enrollment>
  <condition>Advanced Melanoma</condition>
  <arm_group>
    <arm_group_label>HCP and Patient inclusion</arm_group_label>
    <description>HCP inclusion - HCP Experience with treatment of patients with study compound who have been exposed to risk minimization tools&#xD;
Patient inclusion - Patients treated with study compound as per label who have been exposed to the risk minimization materials</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <arm_group_label>HCP and Patient inclusion</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        HCPs and Patients in EU member states where YERVOY has been marked for atleast six months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        For more information regarding BMS clinical trial participation, please visit&#xD;
        www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  HCP experienced in the treatment of patients with the research compound and patients&#xD;
             that have received at least one dose&#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>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bristol-Myers Squibb</name>
      <address>
        <city>Princeton</city>
        <state>New Jersey</state>
        <zip>08540</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>St. Ives</city>
        <state>Cambridgeshire</state>
        <zip>PE27 5BZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS clinical trial educational resource</description>
  </link>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>March 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>December 18, 2015</last_update_submitted>
  <last_update_submitted_qc>December 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2015</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>Melanoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ipilimumab</mesh_term>
  </intervention_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/NCT02224768
org study id: CA184-242
nct id: NCT02224768
lead sponsor: 
has dmc: No
To evaluate the effectiveness of the YERVOY® educational Risk Minimization (RM) tools in
      terms of awareness about these tools, their utilization, knowledge and comprehension of
      Immune Related Adverse Reaction (irAR)s, and appropriate behavior by Healthcare Professional
      (HCP)s and patients
A total sample size of 160 to 200 HCPs and 160 to 200 patients
observational model: Cohort
time perspective: Cross-Sectional
measure: The proportion of YERVOY HCPs that are aware of the existence of the risk communications tools and how the tools were accessed (i.e. paper or electronic versions)
time frame: 6 months
description: Distribution metrics and awareness of the tools from responses through the survey will be analysed and descriptive statistics will be used within the different participant groups
measure: Questionnaire: "Who uses the RM communication tools, how, when they are used and how often they are used"
time frame: 6 months
description: Web downloads metrics will be collected and the usage of tools from responses in the survey will be analysed, and descriptive statistics will be used within the participant groups
measure: Level of knowledge and comprehension of the key elements of important identified risks associated with YERVOY treatment based on the scores obtained from the Questionnaire Surveys
time frame: 6 months
description: Knowledge and comprehension in HCPs and patients, the knowledge surveys will provide the following data
Total number of responses to the question including the proportions of correct answers to questions where appropriate
Number or frequency and proportion of response options selected
Percentage of responses/total responses per option
Mean value and standard deviation (for appropriate questions)
From the obtained data, Acceptable levels of correct responses will be determined, post data analysis, reporting and discussion with EMA, to set baseline levels for potential future evaluations and then the scores will be assessed
measure: HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys
time frame: 6 months
description: For determining appropriate behaviours in HCPs and patients, ideal expected behaviours will be mapped to the ideal care pathway from the Failure Modes and Effects Analysis (FMEA) as described in the RMP. The metrics will show:
Total of number of participants answering the question.
Proportions of participants providing correct answers (to identify knowledge and comprehension)
Proportion of participants showing expected (ideal) behaviour - i.e. correct answers to individual questions.
Proportion of participants showing non-ideal behaviour - i.e. partially correct or incorrect answers to individual questions.
Analysis will examine knowledge, comprehension and behaviours for different participant types (HCP, Hospital type and Country)
arm group label: HCP and Patient inclusion
description: HCP inclusion - HCP Experience with treatment of patients with study compound who have been exposed to risk minimization tools
Patient inclusion - Patients treated with study compound as per label who have been exposed to the risk minimization materials
intervention type: Drug
intervention name: Ipilimumab
arm group label: HCP and Patient inclusion
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
country: United Kingdom
country: United States
url: http://www.bms.com/studyconnect/Pages/home.aspx
description: BMS clinical trial educational resource
responsible party type: Sponsor
mesh term: Melanoma
mesh term: Ipilimumab