Patients Satisfaction With the Outcomes of Expensive Cytotoxic Agents

NCT ID: NCT02649725

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1800 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2019-01-31

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, pemetrexate 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 and More research team) to produce any text, figures, tables or illustrations from this study in future works of his own.

Conditions

Patient's Satisfaction

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Interventions

patient's satisfaction

Questionnaire based measurement.

Intervention Type: BEHAVIORAL

Eligibility 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

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.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

International Medical Center of Egypt.

UNKNOWN

Sponsor Role: collaborator

Metghamr Cancer Center.

UNKNOWN

Sponsor Role: collaborator

Benha University

OTHER

Sponsor Role: collaborator

Misr University for Science and Technology

OTHER

Sponsor Role: collaborator

Kuwait Cancer Control Center

OTHER

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Ellithy

Associate professor of clinical oncology.Faculty of Medicine.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha S Elbaghdady, Specialis

Role: STUDY_DIRECTOR

Misr University for Science and Technology

Locations

Faculty of Medicine. AIn Shams University

Cairo, Elabbasia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud A Ellithy, Consultant

Role: CONTACT

ellithym@med.asu.edu.eg

01000069694 ext. 002

Lamiaa Elwakil, Consultannt

Role: CONTACT

lamywak@yahoo.com

01005201099 ext. 002

Facility Contacts

Mahmoud Ellithy, Consultant

Role: primary

ellithym@med.asu.edu.eg

01000069694 ext. 002

Lamiaa Elwakil, Pharmaciest

Role: backup

lamywak@yahoo.com

01005201099 ext. 002

Other Identifiers

Cure and more2

Identifier Type: -

Identifier Source: org_study_id