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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02630979
Other study ID # Cure and more1
Secondary ID
Status Recruiting
Phase N/A
First received December 6, 2015
Last updated March 26, 2017
Start date November 2015
Est. completion date December 2017

Study information

Verified date May 2016
Source Ain Shams University
Contact Mahmoud Ellithy, Consultant
Phone 01000069694
Email ellithym@med.asu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Physicians ranked from senior resident to professional consultants

Exclusion Criteria:

- Junior residents.

Study Design


Related Conditions & MeSH terms

  • Physician Satisfaction With the Outcomes of Cytotoxic Drugs

Intervention

Behavioral:
Measuring satisfaction, knowledge and bias
Questionnaire based assessment.

Locations

Country Name City State
Egypt Faculty of Medicine. AIn Shams University Cairo Elabbasia

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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