OBJECTIVES: The main aim of this pilot RCT is to determine the feasibility and preliminary efficacy of integrating CPs into the MDT for cancer pain management on the clinical outcomes of cancer patients experiencing pain.
METHODS: This study protocol outlines two-armed multicenter pilot RCT. Cancer patients suffering from pain will be randomly allocated to receive either clinical pharmacy services, i.e., PharmaCAP trial intervention from the CP, or the usual standard care (i.e., control group). Patients will be recruited consecutively from two hospitals in Kathmandu valley, Nepal. The outcomes will be assessed at baseline (pre-intervention) and 4 weeks post-intervention. The primary feasibility outcomes will include eligibility rate, recruitment rate, willingness to participate, acceptability of screening procedures and random allocation, possible contamination between the groups, intervention fidelity and compliance, treatment satisfaction, and patient understanding of the provided interventions. Subsequently, the primary clinical outcome, i.e., pain intensity of cancer patients, will be assessed. The secondary clinical outcomes will include health-related quality of life (HRQoL), anxiety, depression, adverse drug reactions, and patient medication compliance following the integration of CP into the healthcare team.
DISCUSSION: The feasibility and potential for integrating CP involvement in MDT to improve clinical outcomes of cancer patients with pain will be evaluated through the PharmaCAP trial.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05021393. Registered on 25th August 2022.
MATERIALS AND METHODS: The cross-sectional validation study utilized a convenience sampling method. Initially, a pre-test was conducted with 25 patients. The MARS-5 was then forward and backward translated following the EORTC QLG translation procedure. The final translated version was reviewed by experts and subjected to a second pre-test. Construct validity was assessed through principal component analysis, and internal consistency was measured using Cronbach's alpha coefficient. Inter-rater reliability was evaluated using the Intra-Class Correlation coefficient (ICC).
RESULTS: The study included 204 cancer patients (ages 18-86, 55% female). The Nepalese version of the MARS-5 was translated without significant issues and underwent pre-testing with participants. Participants discussed the scale during these pre-tests, providing feedback on its clarity and comprehensibility. While formal assessment tools were not employed, the iterative nature of the pre-testing process allowed for the refinement of the translation based on participant feedback, indicating a robust understanding of the scale among participants. The ICC of test-retest reliability was found to be 0.860. The Kaiser Meyer Olkin's value was 0.690, and Cronbach's alpha was 0.72, indicating good construct validity and high internal consistency. The medication non-adherence rate was 11.3%.
CONCLUSION: The MARS-5 was successfully translated, culturally adapted, and validated in Nepalese for use among Nepalese cancer patients experiencing pain. The Nepalese version of MARS-5 is a reliable tool for evaluating medication adherence in this population.
OBJECTIVES: This study aimed to assess the feasibility and acceptability of integrating clinical pharmacists into the multidisciplinary team (MDT) to manage cancer pain and assess preliminary outcomes in cancer patients receiving pain treatment. This pilot study was undertaken to inform a future definitive randomized controlled trial (RCT).
METHODS: The protocol was registered with ClinicalTrials.gov (NCT05021393). The PharmaCAP trial was conducted in two oncology centers in Nepal, where patients were randomly enrolled into usual care (UC) or an intervention group (PharmaCAP). The latter received a clinical pharmacist-led medication review, which involved a comprehensive assessment of the patient's current medications, identification of potential drug-related problems, and personalized recommendations for optimizing pain management. This was accompanied by pain assessment, education and counseling on pain management strategies. Baseline and 4-weeks post-intervention assessments measured primary outcomes, i.e., feasibility metrics (recruitment of the patients, retention of patients, patient satisfaction). Secondary outcomes included pain intensity, health-related QoL, anxiety, depression, barriers to pain management, and medication adherence at 4 weeks.
RESULTS: Out of 140 screened patients, 108 were evaluated for eligibility, with 16 opting out primarily due to lack of interest (n = 11) and communication barriers (n = 5). A total of ninety-two participants with cancer pain were randomized into two groups, with 91 patients successfully recruited and 85 (93.4%) completing 4 weeks post-intervention assessment). Completion rates for the UC and PharmaCAP groups were 91.3% and 93.4%, respectively. The primary feasibility outcomes were positive: 100% of patients found random allocation acceptable. Retention rates were high, with 91.3% in the UC group and 93.4% in the PharmaCAP group, despite a few dropouts due to being unreachable, COVID-related issues, and changes in treatment centers. No evidence of contamination between groups was found, as participants did not discuss interventions or influence each other's attitudes, ensuring effective isolation of interventions The PharmaCAP intervention showed significant improvement in QoL (P
OBJECTIVE: To synthesize definitions of opioid stewardship proposed by clinical practice guidelines and professional societies, and to offer a proposal for a universally acceptable definition.
METHODS: Systematic literature searches were performed (earliest records to May 2022) in six databases (MEDLINE, EMBASE, APA PsycINFO, Scopus, and CENTRAL) and grey sources guidelines development bodies and professional societies through Google. The conventional but widely applied content analysis and word frequencies were used to analyze the definitions and scope of practice.
RESULTS: After removing duplicates, 449 articles were retrieved (439 databases and registers and 11 from other sources), 19 of which included a definition of "opioids stewardship". A total of 12 themes was identified in the definitions, including 1) improvement or appropriateness of prescribing opioids use, 2) mitigation of risk from opioids, 3) monitoring opioid use, 4) evaluation of opioid use, 5) judicious opioid use, 6) appropriateness of opioid disposal, 7) identification and treatment of opioid use disorder, 8) reduction in mortality associated with opioid overdoses, 9) appropriate procurement practices, 10) appropriate storage, 11) promoting better communications between patients and prescribers including education provision and 12) patient-centered decision-making.
CONCLUSION: Opioid stewardship is inconsistently defined across professional and research literature. While there is a greater focus on appropriateness and need for improvement of prescribing and monitoring of opioid use, the importance of communications between patients and prescribers, and patient involvement in both prescribing and deprescribing decision-making remains sparse. A comprehensive definition has been proposed as part of the work. There is a need to develop and validate the proposed definition and scope of practice to promote rationale for opioid prescribing, use and attainment of favourable outcomes through international consensus involving practitioners, researchers, and patients.