YERVOY® Risk Minimization Tool Effectiveness Evaluation Survey

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Completed

CT.gov ID

NCT02224768

Collaborator

(none)

158

Enrollment

Locations

Duration (Months)

Patients Per Site

19.5

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Advanced Melanoma	Drug: Ipilimumab

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

158 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

YERVOY Risk Minimisation Tool Evaluation Survey

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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) [6 months]
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
Questionnaire: "Who uses the RM communication tools, how, when they are used and how often they are used" [6 months]
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
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 [6 months]
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
HCP and patient behaviours via behavioural questions and scenarios based on the scores obtained from the Questionnaire Surveys [6 months]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bristol-Myers Squibb	Princeton	New Jersey	United States	08540
2	Local Institution	St. Ives	Cambridgeshire	United Kingdom	PE27 5BZ

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

BMS clinical trial educational resource

Publications

None provided.

Responsible Party:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT02224768

Other Study ID Numbers:

CA184-242

First Posted:

Aug 25, 2014

Last Update Posted:

Dec 21, 2015

Last Verified:

Dec 1, 2015

Additional relevant MeSH terms:

Melanoma

Ipilimumab

Study Results

No Results Posted as of Dec 21, 2015