Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202101898000346 Date of Approval: 21/01/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Improving opioid analgesics use in Cancer by using media tools addressing selected barriers.
Official scientific title Feasibility and Outcomes of a Media-based Intervention Against Attitudinal Barriers of Cancer Patients and their Family Caregivers Towards Opioid Analgesics Use.
Brief summary describing the background and objectives of the trial Pain Prevalence is high in cancer patients, and it increases with disease progression or metastasis. Pain could negatively affect patients' mental and daily life activities including administration of Opioid analgesics. Thus, a patient might depend on a family care giver's assistance to use Opioids for pain. Many society, family, and patient-related barriers are reported in literature to be contributing to under-treatment of pain by Opioid analgesics. If Cancer patients &/or their family care givers had an attitudinal barrier like fear of addiction resulting from the Opioid, it may be more probable that these individuals might somehow withhold their medication without physician's recommendation. Fortunately, certain negative barriers towards Opioid analgesics were enhanced after brief education provided during a trial. This short session was held in clinics, and addressed Cancer patients and their family carers via both written and video-based media. Our trial aims to study feasibility of educating participating Egyptian cancer patients and their family care givers, in the city of Alexandria, via one of two different pre-designed media tools (video/written). Our second goal will be to compare outcomes of education in terms of participants' attitudinal barriers and reported practices of using Opioids, as well as patients' pain level.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 31/01/2021
Actual trial start date 29/12/2020
Anticipated date of last follow up 14/03/2021
Actual Last follow-up date 10/04/2022
Anticipated target sample size (number of participants) 104
Actual target sample size (number of participants) 127
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Innovative promotion At least single exposure during the first session. Later exposure during the follow up period is optional. Exposure to the material and any related inquiries last for not more than 10 minutes during the first session. A participant patient and his/her carer (a dyad) allocated to this arm (intervention) will receive promotion on Opioid analgesics. It will be based on audio-visual media and will display novel promotional video for the recipients. Afterwards, explanations and discussions will take place with patients and caregivers to address any concerns. The video primarily addresses certain attitudinal barriers towards use of Opioids for cancer pain, and the scenario is rooted from an actual patient case that has been met in clinics. 52
Control Group Traditional promotion At least single exposure during the first session. Later exposure during the follow up period is optional. Exposure to the material and any related inquiries last for not more than 10 minutes during the first session. A participant patient and his/her carer (a dyad) allocated to this arm (control) will receive promotion on Opioid analgesics. It will be based on usual health information models and will address recipients using a printed written tool. Afterwards, explanations and discussions will take place with patients and caregivers to address any concerns. The material's content addresses primarily selected attitudinal barriers towards use of Opioids for cancer pain. 52 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients and caregivers should be adults above 18 years old. Patients should fulfill the following criteria: - Self-report a diagnosis of cancer and present at least one prescription for opioid analgesia. - Report they have been experiencing pain for more than 1 month. The main caregiver should self-report being the member attending the clinic with the patient, and being actively involved in pain evaluation and analgesic use at home. In case of patients and/or the main caregivers being illiterate, the questionnaires written templates will be administered by the researcher without any rewording or rephrasing. This is to simulate conditions as if the patient/carer would read the questionnaires by him/herself. - Patients or caregivers who report receiving a form of pain information, whether at the time of the study or within 3 previous months. - Radiotherapy planned or received within the last two weeks before inclusion. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 100 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 10/05/2020 Alexandria University High Institute of Public Health Ethics committee
Ethics Committee Address
Street address City Postal code Country
Abou Keer st ElHadarah El Bahary Alexandria 21519 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/08/2020 RE committee Central directorate for research and health development Training and research sector Ministry of health and population.
Ethics Committee Address
Street address City Postal code Country
3 Magles Elshaab st new administrative building 7th floor Cairo 11516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Practice change represented by withholding treatment of the opioid analgesic. At baseline before exposure to promotion. Then, at the follow up session after at least 3 weeks.
Secondary Outcome Attitudinal barriers At baseline before exposure to promotion. Then, at follow up session after at least 3 weeks.
Secondary Outcome BPI pain scores reported by patients if capable Baseline and at follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out patient oncology clinics Ayadi ElMostakbal oncology hospital. Acacia St, Abis, Moharam Bek Alexandria Egypt
out patient oncology clinics Gamal Abdelnaser Hospital Abou keer st, El Hadara Bahary. Alexandria Egypt
Outpatient pain clinic oncology dpt Medical research institute hospital Aboukeer st, El Hadara Bahary Alexandria Egypt
outpatient clinics Al kabbary general hospital El Amir Loaloa St. - In Front Of Adel El Far Supermarket - El Qabbary Alexandria Egypt
Outpatient oncology clinics Main university teaching hospital Champollion Street El-Khartoum Square Azarita Medical Campus Alexandria Egypt
Outpatient oncology clinic Medical research Institute hospital Abou Keer st El Hadara El Bahary Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Academy of scientific research and technology 101 Kasr Al-aini St, Cairo, Egypt Cairo Egypt
self funding 182 Omar Lotfy st Sporting Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Academy of scientific research and technology 101 Kasr al-aini st Cairo Egypt Funding Agency
Secondary Sponsor Alexandria University 22 El-Guish Road, El-Shatby Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Main teaching hospital faculty of Medicine Alexandria University Champollion Street El-Khartoum Square Azarita Medical Campus Alexandria Egypt
Ayadi El Mostakbal Oncology hospital Acacia St, Abis, Moharam Bek Alexandria Egypt
Medical research institute 169 Abou Keer st Al Hadrah Bahri, Qism Bab Sharqi Alexandria Egypt
Al Kabbary general hospital Ministry of health and population Al Amir Looloo, Al Qabari, Qism Mina El-Basal Alexandria Egypt
Gamal abdel nasser hospital General authority for health insurance Abou Keer st ElHadara el bahary Alexandria Egypt
Nijmeh ALAtiyyat Faculty of Nursing The Hashemite University Zarqa Jordan
Aya Hasan Bahnasy Omar Lotfy, sporting Alexandria Egypt
Salma Mahdy Elmahmoudeya st. Green plaza complex Alexandria Egypt
Dalia Elzayat Elmahmoudeya st, green plaza complex Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abouzeid abozozzaa@gmail.com 00201005216409 182 Omar Lotfy st Sporting
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Ahmed Abouzeid abozozzaa@gmail.com 00201005216409 182 Omar Lotfy st Sporting
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abouzeid abozozzaa@gmail.com 00201005216409 182 Omar Lotfy st Sporting
City Postal code Country Position/Affiliation
Alexandria Egypt Assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Results will be reported during presentation of the thesis and will be available for scientific publication. A copy of the thesis will be available at the High Institute of Public Health library, Bibliotheca Alexandrina library, Alexandria Central Library and Ainshams University library. Findings will also be reported to the responsible authorities. We will share summary results pertaining to all of the individual participant data collected during the trial, after deidentification. Study Protocol Results will be reported during presentation of the thesis. IPD/additional documents will be available for sharing Beginning 9 months and ending 36 months following article publication. Sharing might be allowed with researchers who provide a methodologically sound proposal. Permitted types of data analysis are those which will achieve aims in the approved proposal. Proposal should be directed to the PI (abozozzaa@gmail.com) who will then forward it to the trial's supervisors. The supervisors will decide whether to grant access based on the proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information