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ClinicalTrials.gov PRS DRAFT Receipt (Working Version)
Last Update: 01/22/2016 00:13
ClinicalTrials.gov ID: NCT02649725
Study Identification
Unique Protocol ID: Cure and more2
Brief Title: Patients Satisfaction With the Outcomes of Expensive Cytotoxic Agents
Official Title: Prospective Questionnaire Based Observational Study Measuring the Degree of
Patient's Satisfaction With the Outcomes of Expensive Cytotoxic Agents.
Secondary IDs:
Study Status
Record Verification: January 2016
Overall Status: Recruiting
Study Start: January 2016
Primary Completion: November 2018 [Anticipated]
Study Completion: January 2019 [Anticipated]
Sponsor/Collaborators
Sponsor: Ain Shams University
Responsible Party: Principal Investigator
Investigator: Mahmoud Ellithy [mellithy]
Official Title: Associate professor of clinical oncology.Faculty of Medicine.
Affiliation: Ain Shams University
Collaborators: Ain Shams University
International Medical Center of Egypt.
Metghamr Cancer Center.
Banha University
Misr University for Science and Technology
Kuwait Cancer Control Center.
Oversight
FDA Regulated?: No
IND/IDE Protocol?: No
Review Board: Approval Status: Not required
Board Name: Ain Shams University, Faculty of Medicine institutional review board
Board Affiliation: Ain Shams University
Phone:
Email: ellithym@med.asu.edu.eg

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Data Monitoring?: No
Plan to Share Data?: No
Oversight Authorities: Egypt: Ministry of Higher Education
Study Description
Brief Summary: The purpose of this study is to determine whether there is positive (beneficial) impact of
expensive cytotoxic agents on the cancer patients. It is a questionnaire based study that
will be filled by the cancer patients without obligations.
Detailed Description: This is a prospective observational questionnaire based study measuring the degree of
patient satisfaction with the outcomes of some expensive cytotoxic agents.
The tested drugs are trastuzumab, lapatinib, sunitinib, m tor inhibitors, sorafenib,
cetuximab, panitumumab, bevacizumab, erlotinib, rituximab, imatinib mesylate, gefitinib,
abiraterone acetate, cabazitaxel, pertuzumab, fulvestrant and crizotinib.
The evaluation will be through a predesigned template questionnaire that will be
applied to all the tested drugs. The questions are divided into five categories measuring
five items, the negative impact of the drug on patient’s finances, satisfaction with
drug efficacy, toxicity and effect on quality of life, satisfaction with drug availability in
the market and satisfaction with the received education from the treating physician
about the drug before usage. A predesigned questionnaire based scoring system will
categorizes the processed data to low, intermediate and high score for each of the five
measured topics. The data will be processed and each drug will acquire low, moderate
or high score. Subsequent recommendations for revision of the drug price, cost effective
analysis studies, physician education about drug pharmaceutical perspectives will be
elaborated for some drugs. The study will clarify the most annoying and frequently
reported side effect for each drug and will suggest recommendations for its treatment.
The study is currently recruiting patients.
The study is currently accepting to add authors (Oncology physicians) who can fulfill the
following prerequisites:
1. Answer a questionnaire that will be mailed to him upon request and propagate
this questionnaire to 10 oncology physicians in his center to answer them. (The
11 questionnaires should be scanned and mailed to ellithym@med.asu.edu.eg.
or given as hard copies to Dr Mahmoud Ellithy (Mobile: +01000069694).
(This questionnaire is designed to be answered by oncology physicians to
measure their degree of satisfaction with the outcomes of expensive cytotoxic
agents).
The questionnaire can be answered electronically online https://
www.surveymonkey.com/r/Cureandmore. (for oncologist with foreign nationality
who want to share as an author. Egyptian oncologists should fill a hard copy not
online).
Disclosure: The Questionnaire for the physicians is a clinical trial registered
clinical trials.gov with NCT02630979. URL. https://clinicaltrials.gov/ct2/show/
nct02630979.
2. Each author must share with at least 90 patients with at least 5 patients for
each drug. The maximum allowed numbers of authors from each center are two
authors sharing with 180 patients till closure of the study in 30th January 2019.
3. Share with any new idea that will add benefit to the study. ( Item 1 and 2 are
mandatory).
The Oncologist who want to share as an author in this study must sign a memorandum
of aggrement consenting for the accuracy, confidentiality and validity of the data with a
copyright, stating that he must obtain a written permission from the research team (Cure

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and More research team) to produce any text, figures, tables or illustrations from this
study in future works of his own.
Conditions
Conditions: Patient's Satisfaction
Keywords:
Study Design
Study Type: Observational [Patient Registry]
Observational Study Model: Ecologic or Community
Time Perspective: Prospective
Biospecimen Retention: None Retained
Biospecimen Description:
Enrollment: 1800 [Anticipated]
Number of Groups/Cohorts: 1
Target Follow-Up Duration: 3 Months
Groups and Interventions
Intervention Details:
Behavioral: patient's satisfaction
Questionnaire based measurement.
Outcome Measures
Primary Outcome Measure:
1. The patient's satisfaction questionnaire
[Time Frame: Two years] [Safety Issue: No]
Eligibility
Study Population: Cancer patients who are willing to answer the questionnaire voluntarily.
Sampling Method: Non-Probability Sample
Minimum Age: 17 Years
Maximum Age: 70 Years
Gender: Both
Accepts Healthy Volunteers?: No
Criteria: Inclusion criteria:
1. The patient should be willing to share in the study.
2. The patient should have full mental power to answer the questionnaire.
3. Adult from 17 to 70 years.
4. Patient should be able to complete the course of treatment without interruption
due to financial issues or other issues like transportation obstacles.
Exclusion criteria:

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1. The patient with psychological disease that impairs credibility of his answer.
2. Patient with special requirements/difficulties with communications.
3. Patient who have difficulty with their memory e.g. recall of events, learning new
things, remembering appointments.
4. Patient who have epilepsy blackouts or dizzy spills.
5. Patient who have any visual impairment other than standard glasses.
Contacts/Locations
Central Contact: Mahmoud A Ellithy, Consultant
Telephone: 01000069694 Ext. 002
Email: ellithym@med.asu.edu.eg
Central Contact Backup: Lamiaa Elwakil, Consultannt
Telephone: 01005201099 Ext. 002
Email: lamywak@yahoo.com
Study Officials: Noha S Elbaghdady, Specialis
Study Director
Misr University for Science and Technology
Locations: Egypt
Faculty of Medicine. AIn Shams University
[Recruiting]
Cairo, Elabbasia, Egypt
Contact: Mahmoud Ellithy, Consultant 01000069694 Ext. 002
ellithym@med.asu.edu.eg
Contact: Lamiaa Elwakil, Pharmaciest 01005201099 Ext. 002
lamywak@yahoo.com
Principal Investigator: Mahmoud A Ellithy, Consultant
Sub-Investigator: Lamiaa Elwakil, Pharmaciest
Sub-Investigator: Noha Elbaghdady, Pharmaciest
Sub-Investigator: Abdelmonem A Elsaid, Consultant
Sub-Investigator: Heba Abdullah, Specialist
References
Citations:
Links:
Study Data/Documents: Type: Study Protocol
For any details contact. ellithym@med.asu.edu.eg
U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services