YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey

YERVOY Risk Minimisation Tool Evaluation Survey

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

Study Overview

• Status: Completed
• Conditions: Advanced Melanoma
• Intervention / Treatment: Drug: Ipilimumab

Detailed Description

A total sample size of 160 to 200 HCPs and 160 to 200 patients

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • St. Ives, Cambridgeshire, United Kingdom, PE27 5BZ
      • Local Institution
• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • Bristol-Myers Squibb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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; 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	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: 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)	6 months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): November 1, 2015
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: August 22, 2014
• First Posted (ESTIMATE): August 25, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): December 21, 2015
• Last Update Submitted That Met QC Criteria: December 18, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Ipilimumab
• Other Study ID Numbers: CA184-242