YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey

NCT02224768 | Completed

• 1 other identifier: CA184-242
• Study Type: observational
• Target: 158
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Advanced Melanoma

Outcome Measures

Primary Outcomes (4)

• 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)

  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

  6 months

• Questionnaire: "Who uses the RM communication tools, how, when they are used and how often they are used"

  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

  6 months

• 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

  Knowledge and comprehension in HCPs and patients, the knowledge surveys will provide the following data 1. Total number of responses to the question including the proportions of correct answers to questions where appropriate 2. Number or frequency and proportion of response options selected 3. Percentage of responses/total responses per option 4. 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

  6 months

• HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys

  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: 1. Total of number of participants answering the question. 2. Proportions of participants providing correct answers (to identify knowledge and comprehension) 3. Proportion of participants showing expected (ideal) behaviour - i.e. correct answers to individual questions. 4. 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)

  6 months

Study Arms (1)

HCP and Patient inclusion

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

Drug: Ipilimumab

Interventions

Ipilimumab DRUG

HCP and Patient inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

HCPs and Patients in EU member states where YERVOY has been marked for atleast six months

You may qualify if:

• HCP experienced in the treatment of patients with the research compound and patients that have received at least one dose

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Bristol-Myers Squibb

Princeton, New Jersey, 08540, United States

Location

Local Institution

St Ives, Cambridgeshire, PE27 5BZ, United Kingdom

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

Ipilimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: August 25, 2014
• Study Start: July 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 21, 2015

Record last verified: 2015-12

Locations

US (1); GB (1)