Clinical trial NCT02649725: 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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient's Satisfaction
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: International Medical Center of Egypt.
name: Metghamr Cancer Center.
name: Benha University
name: Misr University for Science and Technology
name: Kuwait Cancer Control Center
First posted: 2016-01-07
Enrollment: 1800
Sex: ALL
Minimum age (years): 17
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer patients who are willing to answer the questionnaire voluntarily.

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.

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.

Primary outcomes:
measure: The patient's satisfaction questionnaire
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine. AIn Shams University
state: Elabbasia
Study officials:
affiliation: Misr University for Science and Technology
name: Noha S Elbaghdady, Specialis
role: STUDY_DIRECTOR
References: