Physician Satisfaction With the Outcomes of Cytotoxic DrugsNCT02630979
Oncologists Satisfaction With Outcomes of Some Cytotoxic Agents
An observational study of Physician Satisfaction With the Outcomes of Cytotoxic Drugs, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study measures the degree of oncology physician satisfaction with the outcomes of some cytotoxic agents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physician Satisfaction With the Outcomes of Cytotoxic Drugs
- What is being tested?
- Measuring satisfaction, knowledge and bias
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Medical or clinical oncology doctors
Who may be able to join
- Physicians ranked from senior resident to professional consultants
Who cannot join
- Junior residents.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine. AIn Shams University
Cairo, Elabbasia
Mahmoud Ellithy, Consultant, 01000069694 ext. 002, ellithym@med.asu.edu.eg
Lamiaa Elwakil, Pharmaciest, 01005201099 ext. 002, lamywak@yahoo.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Measuring satisfaction, knowledge and bias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring satisfaction, knowledge and biasBehavioural
Questionnaire based assessment.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Clinical and medical oncology physicians. Receives: Behavioral: Measuring satisfaction, knowledge and bias |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physician Satisfaction With the Outcomes of Cytotoxic DrugsStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ellithy, Ain Shams University
- Investigators
- Mahmoud Ellithy, Consultant, Principal investigator, Faculty of Medicine. Ain Shams UniversityNoha Salaheldin elbogdady, Pharmaciest, Study director, Misr university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630979
- Sponsor's protocol ID
- Cure and more1
- Status last verified
- May 2016
- First submitted
- 6 Dec 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Questionnaire Based Study Measuring Oncology Physicians Knowledge and Satisfaction With the Outcomes of Expensive Cytotoxic Agents
- ClinicalTrials.gov ID
- NCT02630979
- Acronym / sponsor ID
- Cure and more1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study measures the degree of oncology physician satisfaction with the outcomes of some cytotoxic agents.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Behavioral: Measuring satisfaction, knowledge and biasClinical and medical oncology physicians. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical or clinical oncology doctors
Key inclusion criteria (1 listed)
- Physicians ranked from senior resident to professional consultants
Key exclusion criteria (1 listed)
- Junior residents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measuring satisfaction, knowledge and biasQuestionnaire based assessment. | Behavioural | No treatment |
Primary outcome
Questionnaire based measurement of the degree of physician satisfaction with the results and toxicity of some cytotoxic drugs.
Time frame: One year
A predesigned questionnaire based scoring system will categorise the degree of satisfaction to low, intermediate and high score.
Questionnaire based measurement of the degree of physician orientation with pharmaceutical perspectives of some cytotoxic drugs.
Time frame: One year
A predesigned questionnaire based scoring system will categorise the degree of orientation to low, intermediate and high score.
Questionnaire based measurement of the degree of physician adherence to guidelines in prescribing some cytotoxic drugs.
Time frame: One year
A predesigned questionnaire based scoring system will categorise the degree of adherence to guidelines to low, intermediate and high score.
Questionnaire based measurement of the degree of physician bias while prescribing some cytotoxic drugs.
Time frame: One year
A predesigned questionnaire based scoring system will categorise the degree of bias to low, intermediate and high score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Ellithy, Consultant principal investigator
Faculty of Medicine. Ain Shams University
Noha Salaheldin elbogdady, Pharmaciest study director
Misr university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Physician Satisfaction With the Outcomes of Cytotoxic Drugs, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Ellithy, Consultant (01000069694 ext. 002, ellithym@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire based measurement of the degree of physician satisfaction with the results and toxicity of some cytotoxic drugs. (time frame: One year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.