Oncologists Satisfaction With Outcomes of Some Cytotoxic Agents

Prospective Observational Questionnaire Based Study Measuring Oncology Physicians Knowledge and Satisfaction With the Outcomes of Expensive Cytotoxic Agents

The study measures the degree of oncology physician satisfaction with the outcomes of some cytotoxic agents.

Study Overview

• Status: Unknown
• Conditions: Physician Satisfaction With the Outcomes of Cytotoxic Drugs
• Intervention / Treatment: Behavioral: Measuring satisfaction, knowledge and bias

Detailed Description

This is a prospective observational questionnaire based study measuring the degree of satisfaction of medical oncologists with the results of some expensive cytotoxic agents. The study also measures the physician knowledge with the toxicity profile of the tested drugs, pharmaceutical perspectives, methods of administration, adherence to guidelines and the degree of bias of the physicians when prescribing this drugs.

The tested drugs are trastuzumab, lapatinib, sunitinib, m tor inhibitors, sorafenib, cetuximab, panitumumab, bevacizumab, erlotinib, rituximab, imatinib mesylate, gefitinib, abiraterone acetate, cabazitaxel, pertuzumab, fulvestrant, pemetrexate and crizotinib.

The evaluation will be through a predesigned questionnaire ( 30 questions ). The questions are divided into four categories measuring four items, the degree of physician satisfaction with the drugs results and toxicity profile, orientation with pharmaceutical perspectives of the drugs, adherence to guidelines and degree of bias with pharmaceutical companies complements. A predesigned questionnaire based scoring system will categorise the processed data to low, intermediate and high score for each of the four measured topics. The data will be processed and the degree of satisfaction, orientation with pharmaceutical perspectives, adherence to guidelines and degree of bias will be grade to low, moderate or high. Subsequent recommendations for cost effective analysis, physician education and strict auditing measures for drug prescription will be elaborated for the drugs.

NB: The study will be on two waves. The first wave will evaluate 9 drugs and the second wave will evaluate 8 drugs.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Egypt
  • Elabbasia
    • Cairo, Elabbasia, Egypt
      • Recruiting
      • Faculty of Medicine. AIn Shams University
      • Principal Investigator: Noha Salaheldin Elbogdady, Master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Medical or clinical oncology doctors

Description

Inclusion Criteria:

• Physicians ranked from senior resident to professional consultants

Exclusion Criteria:

• Junior residents.

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No treatment; Clinical and medical oncology physicians.	Behavioral: Measuring satisfaction, knowledge and bias; Questionnaire based assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire based measurement of the degree of physician satisfaction with the results and toxicity of some cytotoxic drugs.	A predesigned questionnaire based scoring system will categorise the degree of satisfaction to low, intermediate and high score.	One year
Questionnaire based measurement of the degree of physician orientation with pharmaceutical perspectives of some cytotoxic drugs.	A predesigned questionnaire based scoring system will categorise the degree of orientation to low, intermediate and high score.	One year
Questionnaire based measurement of the degree of physician adherence to guidelines in prescribing some cytotoxic drugs.	A predesigned questionnaire based scoring system will categorise the degree of adherence to guidelines to low, intermediate and high score.	One year
Questionnaire based measurement of the degree of physician bias while prescribing some cytotoxic drugs.	A predesigned questionnaire based scoring system will categorise the degree of bias to low, intermediate and high score.	One year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Mahmoud Ellithy, Consultant, Faculty of Medicine. AIn Shams University; Study Director: Noha Salaheldin elbogdady, Pharmaciest, Misr university

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 15, 2015

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 26, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: Cure and more1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No