YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey

Advanced Melanoma Clinical Trial

Official title:

YERVOY Risk Minimisation Tool Evaluation Survey

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02224768
• Other study ID #: CA184-242
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: December 18, 2015
• Start date: July 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Advanced Melanoma

Intervention

Drug:
• Ipilimumab

Locations

Country	Name	City	State
United Kingdom	Local Institution	St. Ives	Cambridgeshire
United States	Bristol-Myers Squibb	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form