الفهرس 
INTRODUCTION and Aim of the studyOnly 14 pages are availabe for public view
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Abstract
The prevalence of pain is described as very common in cancer patients.(23) It is about 55% in patients undergoing active treatment, and about 65% in patients with advanced, metastatic, or terminal cancer.(95) Resource-limited countries are characterized by decreased access to essential analgesics(25) and late cancer diagnosis.(26) As a result, prevalence of moderate to severe pain in adult cancer patients in these countries may reach high figures (30-70%).(24) Socio-economic factors such as fear and misconceptions regarding addiction to opioids for palliative care, poverty, illiteracy, and social stigma over the use of morphine are some of the additional factors associated with an increased prevalence of cancer-related pain in low- and-middle-income countries.(28) A cross section sample of out-patient adults who reported cancer pain of moderate or more severity, and who were prescribed analgesics for the study duration, were studied in 2018 in Mansoura. Nearly 62% of the sample was prescribed strong opioids.(32)
Regarding cancer pain control in countries of limited cancer care services, if patients would depend on their family carers for supportive care while at home, the role of the later would be critical. Despite this, a study undergone in Uganda found that family carers had low knowledge about cancer pain management.(36)
According to the latest guidelines, persistent cancer pain should be treated with regularly scheduled analgesics or long-acting analgesics; but, breakthrough pain should be treated with supplemental doses of short-acting analgesics.(19) The same report states that OAs are the principal analgesics for moderate to severe pain, and detailed some advantages for using buprenorphine and methadone.
Egypt’s online drug database enlists hydromorphone and oxycodone.(49) However, these drugs are more expensive and are therefore unaffordable for many cancer patients in Egypt.(50) Interestingly, although codeine is approved as an OA for palliative care, it is available among patients via out-of-pocket purchase of the illegal import formulation, or via dispensing the same formulation inside Alexandria’s main university hospital. Additionally, a legislation that limits oral maximum prescribed dose of morphine to 420 mg per single prescription that is refilled each week is still valid.
Literature identifies lack of knowledge and negative attitudes as the two main barriers hindering cancer pain control for patients (55) or family caregivers (13). An author described these negative attitudes as socio-economic factors, and gave examples as misconception about analgesics (e.g. addiction), and fear of side effects.(56) In addition, an older systematic review concluded in its introduction that non-adherence to analgesics regimens (15) and decreased communication about pain (58) were among the most prevalent patient-related barriers to cancer pain control.(15)
The Arabic version of the barriers questionnaire (ABQ) assesses the extent to which addiction or tolerance to OAs, or OA’s adverse effects represent attitudinal barriers from the point of view of patients or family caregivers.(62) The fear of opioids as analgesics by Egyptian cancer patients was reported in literature.(63) When patients from Cairo and Sharkeya were interviewed, about half of the patients who were prescribed tramadol as an analgesic refused to take it, and the third agreed to administer tramadol but with concerns about addiction. When the refusers were asked about reasons not taking tramadol for cancer pain, more than half reported fears related to addiction.(63)
Attitudinal barriers towards use of OAs for cancer pain may be improved through educational interventions directed to patients. A systematic review reported this in about two thirds of its interventions, while it noticed better adherence to medications in only the half, and found less pain intensity in nearly fifth of the reviewed interventions.(15)
Researchers of a systematic review reported an improvement in knowledge or barriers of cancer patients after receiving pain education in about two thirds of the interventions, while they noticed better adherence to medications in only the half, and less pain intensity in nearly fifth of the reviewed interventions.(15)
Concerning interventions directed to caregivers, a recent research article studied their characteristics like setting, format, and educational materials. This review found that about two thirds of the compiled interventions took place in-person and individually inside health service settings. However, only a quarter supplied the caregivers with materials like handouts or DVDs.(67)
The aim of the current study was to provide cancer patients and their carers in Alexandria with two educational media-based interventional formats that address attitudinal barriers hindering use of opioid analgesics. The specific objectives were:
1) To investigate attitudinal barriers of cancer patients and their main caregivers towards the use of opioid analgesics.
2) To determine the reported practices of cancer patients and caregivers related to the use of opioid analgesics.
3) To design and implement an innovative media-based intervention, and a traditional one based on usual health information models, towards the attitudinal barriers of cancer pain management, among patients and their main caregivers.
4) To compare feasibility of the innovative and the traditional interventions in terms of patients’ acceptability.
5) To compare the outcomes of the innovative and the traditional interventions on:
a- Patients regarding their barriers, reported pain medication practices, and pain level.
b- Caregivers regarding their barriers and reported pain medication practices.
Our block randomized two-arm trial recruited patients proportionately along with their carers from five non-private clinics in Alexandria. Included patients were adults with a cancer diagnosis who have just been prescribed an opioid analgesic for at least one month. Included carers were adults who were responsible for dispensing and/or administering the opioid medication. Cases who consented to participate continued the baseline assessment and were randomly allocated to receive either brochure-based or video-based education. Measured variables included attitudinal barriers via ABQ, reported opioid use practices via a structured interview, and pain level via A-BPI-sf. Cases who were still alive at the follow up point, which was at least 3 weeks after the intervention provision, were analyzed for the same variables assessed at baseline excluding socio-demographic data.
The Arabic barriers questionnaire (ABQ) measures on a 5 point Likert scale the extent of perceiving certain attributes of cancer pain and use of OAs as attitudinal barriers. The questionnaire poses 27 items that address 8 different barriers.(62) Concerning pain intensity, we used the short form(74) of the brief pain inventory (BPI)(78, 79) to assess current, as well as worst, least, and average pain perceived during the past 24 hours, on a NRS [1-10]. As for withholding the OA without medical recommendation, we assessed various forms via a pre-designed scheduled interview. The most important forms were: Complete withholding of the OA for 1 or more days, and partial withholding (dose self-reduction) of the OA which encompassed reducing prescribed frequency and prescribed unit dose.
Other forms of withholding included administering OA on a regular schedule or as needed (prn), and whether the caregiver (CG) delayed the patient’s request to offer a dose of the OA. In addition, we also investigated delaying the scheduled dose, the most important perceived reason for dose self-reduction of OA, occurrence of current or recent OA-related adverse reaction(s), and the main management method for the adverse reaction. The questions were based on tools from previous literature,(76, 77) in addition to some self-designed questions.
The collected data were revised for accuracy and completeness. Data entry and analysis were done using statistical package for the social sciences (SPSS) statistical software.
The study revealed the following main results:
Demographic and clinical data of the studied cancer patients.
▪ More than half (60%) of patients’ baseline sample were females and 75% of the patients were married.
▪ Half of the sample were mid-aged (40-59 years old), and more than the third were elderly (60 years old and above).
▪ 40% finished secondary level of education.
▪ The third were unemployed plus being incapable of working due to their health state.
▪ Vast majority (80%) of patients’ baseline sample were at the metastatic stage of their disease.
Demographic data of the studied cancer patients’ caregivers.
▪ Most (63%) of the caregivers at baseline were females and more than three quarters (77%) were married.
▪ More than two thirds (71%) of carers shared residence with their patients.
▪ The pattern of age and highest attained level of education for carers was similar to that of patients.
▪ About third (36%) of the relations between caregivers and their patients at baseline was marriage.
▪ Nearly 40% of the carers chose “house wives” as regarding employment status.
About 90% of eligible subjects consented to receive the educational intervention. This possibly suggests feasibility of educational interventions as regarding participants’ acceptability.
About 83% of baseline patients were prescribed one OA only regardless NOAs or AAs. Given also that the vast majority of patients were metastatic, who had mean average pain of 6.57 (i.e. moderate degree), and who were prescribed tramadol in three quarters of cases; based on all this, one may draw that the baseline prescribed OA was not optimized to latest guidelines(43), and thus may contribute in part to the moderate pain level reported by patients. Another possible contributor may be non-adherence to the prescribed OA as showed by our results about certain medication use parameters.
Use of Opioid analgesics by participants
We found that, at the baseline or follow up interview: 15-40% of the participants withheld the OA for 24 hours for 1-5 days respectively, about 30% took their OA on as-needed-base (prn), and nearly 15% administered their OA but with hesitation. In addition, 40% of the dyads self-delayed the OA dose or decreased the prescribed daily frequency on their own, whether at baseline or follow up. Finally, about quarter of our sample did not take their OA on the day before the interview. Most prevalent reasons for any of these non-adherence forms were: Holding an attitudinal barrier, and improvement of the patient’s state.
Pain level of cancer patients
Pain level was expressed numerically as perceived by the patient on a 0-10 NRS. The degree of pain perceived by patients before the intervention differed according to the type of pain investigated by the A-BPI-sf. The worst pain was severe (mean=8.17); while least (mean=4.36), average (mean=6.57), or current (mean=5.53) pain were of moderate degree. See Table 4.13. Interestingly, the two education arms showed opposite changes in pain at follow-up, which might have contributed to the net unchanged pattern of pain level for the study sample. Unfortunately, dyads educated by the video reported significant increase in least, average, and current pain (t=2.06, p=0.045; t=11.9, p<0.001, & t=8.7, p<0.001; respectively). On the contrary, average or current pain of patients who received the brochure education improved significantly (t=8.96, p<0.001, & t=6.9, p<0.001; respectively). This improvement might have occurred though correcting the attitudinal barriers towards cancer pain and OAs.
Attitudinal barriers of the participants
The average ABQ score of baseline patients was (3.05±0.44), and nearly the same score was recorded at follow up. This indicates that patients were either neutral, or did not know their position, towards attitudinal barriers of cancer pain and its management. Almost the same scores were recorded for caregivers. ABQ score of patients who received the brochure education decreased significantly (t=2.6, p=0.013). This improvement might have contributed to the improved pain scores reported by patients in the same arm. As for the video arm of promotion, only caregivers demonstrated significant improvement in their barriers (t=2.22, p=0.031).
6.2. Conclusions
Based on the results of this study, the following could be concluded:
● The opioid component in cancer patients is currently not optimized to manage pain properly.
● The two educational interventions did not result in change concerning OA use practices.
● The opposing changes in pain resulting from either of the interventions may have contributed to the constant pain pattern recorded at baseline and follow up.
● Educating patients and caregivers via traditional media like our brochure was accompanied by significant improvement in average or current pain reported by patients. This improvement might be explained partly by the significant decrease in the same patients’ attitudinal barriers.
● Innovative education via the video resulted in worsening of the patients’ least, average, or current pain.
● Patients and their caregivers reported same average ABQ score. Their attitudes towards barriers need to be shifted from the neutral position to the correct position; i.e. less scores.
● Patients’ attitudinal barriers were improved after being educated by the brochure, while similar improvement was achieved for carers via the video promotion.
6.3. Recommendations
The following are the main recommendations for this study:
6.3.1. Recommendations to hospital pharmacies:
⮚ Pharmacies’ managers of Ayadi ALMostakbal, ALkabbary, Alexandria’s main university hospital, and Abdel naser should procure short-acting tablet formulations of oxycodone (5 & 10 mgs) which have just been recently available in Alexandria.
⮚ Remind and/or inform pharmacists and physicians dealing with OAs inside the five hospitals in Alexandria that the Egyptian drug authority’s (EDA) current online registry database approves:
• The following formulations of two guidelines-recommended short acting OAs: Hydromorphone (hard gelatin and prolonged release capsules) and oxycodone (ordinary and prolonged release tablets).
• Tablets combining 30 or 50 mg codeine + 500 or 600 mg paracetamol. (As an official cost-effective alternative to Solpadene®).
• Tramadol (37.5 mg) with paracetamol (325 mg) in a single tablet. (As an official cost-effective alternative to Solpadene®).
• Buccal tablets of fentanyl.
⮚ Remind pharmacists and physicians that doses of around-the-clock OAs should be given at the appropriate fixed intervals of time i.e. the next dose should be given before the effect of the previous dose has worn off.
⮚ Pharmacists and physicians should counsel that the first and last OA’s doses of the day should be linked to the patient’s waking time and bedtime.
⮚ In addition to regular administration, patients should have access to a rescue OA for breakthrough pain. A rescue dose that is 50–100% of the regular 4-hourly dose may be considered. In the absence of evidence, the choice of specific medicine may depend on affordability and ease of administration. This rescue dose should be an immediate-release opioid, not a slow-release opioid.
6.3.2. Recommendations to dispensing/clinical pharmacists
⮚ Based on our experience with patients in various settings, we find the following NCCN, 2023 guidelines recommended for application inside the dispensing pharmacies:
• Along with the educational materials, provide both patients and carers a list of each medication prescribed, a description of “what each medication is for”, and instructions on how and when to take each one.
• Provide a list of potential adverse effects of the dispensed medications and what to do if they occur.
• Provide a list of all medications to be discontinued.
• N.B. Concerning these recommendations, all description should be provided in writing on a dated form and must be reviewed with each patient and family/caregiver.
6.3.3. Recommendation to research
⮚ Future research needs to focus on updating currently available systematic reviews on attitudinal barriers of patients and carers against opioid treatment of cancer pain.
⮚ Future educational research trials with the Egyptian population should have an enhanced methodology compared to ours in order to achieve a significant improvement in attitudinal barriers, adherence to OA, or pain scores. Methodological points include:
- Combining two educational formats inside the interventional arm and rendering the control arm to be a negative one i.e. usual care.
- Tailoring the education program across participants based on the attitudinal barriers of each at baseline.
- Increase frequency of follow up interviews, whether in-person or on-phone.
- Intensifying the educational content for each participant upon emergence of OA-related adverse effects or increase of pain during follow up meetings.
- Consider sponsoring the innovative tool (drama video) so as to include celebrity professional actors who have experience in health media.
6.3.4. Recommendation to physicians
⮚ Encourage oncologists and pain physicians to follow the guidelines recommendations listed above by providing them as both electronic (mobile messages) and printed handout formats.
⮚ Spend some time educating patients and their carers regarding their prescribed analgesics, and addressing thei