Clinical pharmacist interventions on pain management in cancer patients (PharmaCAP) in low resource settings: a multicenter feasibility-pilot randomized controlled trial.

Abstract

Introduction: Cancer pain management is frequently insufficient worldwide, especially in low- and middle-income countries where significant challenges related to workforce resources persist. Clinical pharmacists could potentially enhance outcomes in this context, yet their role remains largely unexplored.

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 < 0.001), physical functioning (P < 0.001), and financial difficulties (P < 0.001). There was also clinical benefit observed in anxiety and depression (P < 0.001) and enhancements in medication adherence (P < 0.001). While pain intensity decreased in both groups, the difference was not statistically significant. Satisfaction with the PharmaCAP intervention was high, with 93.0% of participants expressing satisfaction and 88.3% acknowledging that the clinical pharmacists effectively addressed their drug-related queries.

Conclusion: Findings of this RCT demonstrate that integrating clinical pharmacists into the MDT team in low low-resource setting is feasible and shows promise in improving QoL, reducing anxiety and depression, and enhancing medication adherence among cancer patients. These findings support the feasibility of conducting a full-scale RCT. Enabling clinical pharmacists to assist with cancer pain management in low-resource settings can benefit patients, healthcare teams, and health systems.

Trial registration: ClinicalTrials.gov NCT05021393. Registered on 25th August 2022.