Patient's SatisfactionNCT02649725
Patients Satisfaction With the Outcomes of Expensive Cytotoxic Agents
An observational study of Patient's Satisfaction, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Patient's Satisfaction
- What is being tested?
- patient's satisfaction
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,800 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Jan 2019
- How long will I take part?
- 3 Months
- 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cancer patients who are willing to answer the questionnaire voluntarily.
Who may be able to join
- The patient should be willing to share in the study.
- The patient should have full mental power to answer the questionnaire.
- Adult from 17 to 70 years.
- Patient should be able to complete the course of treatment without interruption due to financial issues or other issues like transportation obstacles.
Who cannot join
- The patient with psychological disease that impairs credibility of his answer.
- Patient with special requirements/difficulties with communications.
- Patient who have difficulty with their memory e.g. recall of events, learning new things, remembering appointments.
- Patient who have epilepsy blackouts or dizzy spills.
- Patient who have any visual impairment other than standard glasses.
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 Questionnaire Based Observational Study Measuring the Degree of Patient's Satisfaction With the Outcomes of Expensive Cytotoxic Agents.
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.
Read the 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:
- 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.
- 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.
- 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
- Being tested
- patient's satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient's satisfactionBehavioural
Questionnaire based measurement.
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's satisfaction questionnaire
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionNov 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient's SatisfactionStudies 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
- 1,800 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- International Medical Center of Egypt., Metghamr Cancer Center., Benha University, Misr University for Science and Technology, Kuwait Cancer Control Center
- Responsible party
- Principal investigator, Mahmoud Ellithy, Ain Shams University
- Investigators
- Noha S Elbaghdady, Specialis, Study director, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02649725
- Sponsor's protocol ID
- Cure and more2
- Status last verified
- May 2016
- First submitted
- 6 Jan 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Questionnaire Based Observational Study Measuring the Degree of Patient's Satisfaction With the Outcomes of Expensive Cytotoxic Agents.
- ClinicalTrials.gov ID
- NCT02649725
- Acronym / sponsor ID
- Cure and more2
- Conditions
- Patient's Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- International Medical Center of Egypt., Metghamr Cancer Center., Benha University, Misr University for Science and Technology, Kuwait Cancer Control Center
- Study start
- Jan 2016
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 7 Jan 2016 (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 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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cancer patients who are willing to answer the questionnaire voluntarily.
Key inclusion criteria (4 listed)
- The patient should be willing to share in the study.
- The patient should have full mental power to answer the questionnaire.
- Adult from 17 to 70 years.
- Patient should be able to complete the course of treatment without interruption due to financial issues or other issues like transportation obstacles.
Key exclusion criteria (5 listed)
- The patient with psychological disease that impairs credibility of his answer.
- Patient with special requirements/difficulties with communications.
- Patient who have difficulty with their memory e.g. recall of events, learning new things, remembering appointments.
- Patient who have epilepsy blackouts or dizzy spills.
- Patient who have any visual impairment other than standard glasses.
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 |
|---|---|---|
| patient's satisfactionQuestionnaire based measurement. | Behavioural | – |
Primary outcome
The patient's satisfaction questionnaire
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Individual participant dataSharing planned: No
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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.
Noha S Elbaghdady, Specialis study director
Misr University for Science and Technology
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 Patient's Satisfaction, 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 4 inclusion and 5 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 3 May 2016. 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 A 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?
The patient's satisfaction questionnaire (time frame: Two years). 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 3 May 2016.