A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada

A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures

This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).

Study Overview

• Status: Withdrawn
• Conditions: Uterine Fibroids

Detailed Description

Data will be collected via web-based data capture by HCPs submitting surveys. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92622
      • Clinical Trials Registry Team

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The survey will endeavor to collect 150 completed HCP surveys.

Description

Inclusion Criteria:

• HCPs have prescribed Fibristal for the indication of uterine fibroids within the past 6 months.
• HCPs have provided permission to share their responses in aggregate to Health Canada.

Exclusion Criteria:

• HCPs who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.
• HCPs who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past 5 years.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of HCPs with correct responses to the knowledge level questions.	Correct responses to knowledge-related questions based on the contents of the Fibristal aRMMs.	18 - 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure .	HCP's recall of receiving and reading the HCP Letter and HCP Brochure .	18 - 24 months
Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card	HCP's recall of distributing the Fibristal Patient Alert Card	18 - 24 months
Percentage of patients who recall counselling patients on information included in the Patient Alert Card	HCP's recall of counselling patients on information included in the Patient Alert Card	18 - 24 months
Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions	Composite score on the level of HCPs knowledge across all knowledge-related questions.	18 - 24 months

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: Ahunna Ukah, Allergan

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): February 28, 2021

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Muscle Tissue; Leiomyoma
• Other Study ID Numbers: CMO-EPI-WH-0618

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
• IPD Sharing Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
• IPD Sharing Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No