临床药师对癌症患者疼痛管理的干预（PharmaCAP试验）：一项随机对照试验的研究方案
Clinical pharmacists' intervention on pain management in cancer patients (PharmaCAP trial): study protocol for a randomized controlled trial.
作者信息
Shrestha Sunil, Blebil Ali Qais, Teoh Siew Li, Sapkota Simit, Kc Bhuvan, Paudyal Vibhu, Gan Siew Hua
机构信息
School of Pharmacy, Monash University Malaysia, 47500, Subang Jaya, Selangor, Malaysia.
Department of Clinical Oncology, Kathmandu Cancer Center, Tathali, Bhaktapur, Bagmati Province, Nepal.
出版信息
J Pharm Policy Pract. 2023 Jan 24;16(1):14. doi: 10.1186/s40545-022-00505-0.
INTRODUCTION
Evidence-based services to support cancer patients with pain via clinical pharmacy services are currently lacking. Therefore, there is a need to undertake a randomized controlled trial (RCT) to explore the effectiveness of clinical pharmacists (CPs)' input into the multidisciplinary team (MDT) in providing better therapeutic outcomes for cancer pain management.
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.
引言
目前缺乏通过临床药学服务为癌症疼痛患者提供循证支持的服务。因此，有必要进行一项随机对照试验（RCT），以探索临床药师（CP）加入多学科团队（MDT）对癌症疼痛管理提供更好治疗效果的有效性。
目的
这项试点RCT的主要目的是确定将CP纳入MDT进行癌症疼痛管理对疼痛癌症患者临床结局的可行性和初步疗效。
方法
本研究方案概述了双臂多中心试点RCT。患有疼痛的癌症患者将被随机分配接受临床药学服务，即来自CP的PharmaCAP试验干预，或常规标准护理（即对照组）。患者将从尼泊尔加德满都谷地的两家医院连续招募。结局将在基线（干预前）和干预后4周进行评估。主要可行性结局将包括符合率、招募率、参与意愿、筛查程序和随机分配的可接受性、组间可能的污染、干预保真度和依从性、治疗满意度以及患者对所提供干预措施的理解。随后，将评估主要临床结局，即癌症患者的疼痛强度。次要临床结局将包括健康相关生活质量（HRQoL）、焦虑、抑郁、药物不良反应以及CP加入医疗团队后患者的用药依从性。
讨论
将通过PharmaCAP试验评估CP参与MDT以改善癌症疼痛患者临床结局的可行性和潜力。
试验注册
ClinicalTrials.gov NCT05021393。于2022年8月25日注册。
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