Pharmacist-Led Management Improves Treatment Adherence and Quality of Life in Opioid-Tolerant Patients With Cancer Pain: A Randomized Controlled Trial

Xiaowei Zheng, Haiying Ding, Silu Xu, Ruixiang Xie, Yuguo Liu, Qing Zhai, Luo Fang, Yinghui Tong, Jiao Sun, Wenxiu Xin, Nan Wu, Juan Chen, Wenna Shi, Ling Yang, Hui Li, Jingjing Shao, Yangkui Wang, Hui Yu, Bo Zhang, Qiong Du, Yezi Yang, Xiaodan Zhang, Cunxian Duan, Qiulin Zhao, Jing Shi, Jing Huang, Qing Fan, Huawei Cheng, Lingya Chen, Sisi Kong, Hui Zhang, Liyan Gong, Yiping Zhang, Zhengbo Song, Yang Yang, Shoubing Zhou, Chengsuo Huang, Jinyuan Lin, Chenchen Wang, Xianhong Huang, Qing Wei, Yancai Sun, Ping Huang, Xiaowei Zheng, Haiying Ding, Silu Xu, Ruixiang Xie, Yuguo Liu, Qing Zhai, Luo Fang, Yinghui Tong, Jiao Sun, Wenxiu Xin, Nan Wu, Juan Chen, Wenna Shi, Ling Yang, Hui Li, Jingjing Shao, Yangkui Wang, Hui Yu, Bo Zhang, Qiong Du, Yezi Yang, Xiaodan Zhang, Cunxian Duan, Qiulin Zhao, Jing Shi, Jing Huang, Qing Fan, Huawei Cheng, Lingya Chen, Sisi Kong, Hui Zhang, Liyan Gong, Yiping Zhang, Zhengbo Song, Yang Yang, Shoubing Zhou, Chengsuo Huang, Jinyuan Lin, Chenchen Wang, Xianhong Huang, Qing Wei, Yancai Sun, Ping Huang

Abstract

Introduction: Opioid-tolerant patients are more likely to deviate from recommended treatments and to experience inadequate analgesia than opioid-naive ones. The aim of this study was to examine whether pharmacist-led management could help improve treatment adherence and quality of life.

Methods: Eligible patients were randomized in a 1:1 ratio to control group and intervention group. The control group received routine education and support, while the intervention group received additional individualized pharmacist-led care. The primary endpoint was treatment adherence in the per-protocol analysis, as evaluated by blinded assessors. An interim analysis was planned when 30% patients completed the study. Alpha was divided into the interim analysis (0.015) and the final analysis (0.035).

Results: In the interim analysis (97 and 87 patients in the control and intervention groups, respectively), the primary endpoint was met. Pharmacist-led intervention significantly increased treatment adherence (93.3 vs. 79.8%; OR: 2.25; 95% CI 1.02, 4.94; P = 0.013), quality of life (0.81 ± 0.17 vs. 0.72 ± 0.25; P = 0.008), and reporting of adverse events (82.7 vs. 61.9%; OR: 1.88; 95% CI 1.16, 3.07; P = 0.004). The two groups did not differ in pain control rate (66.7 vs. 57.1%; OR: 1.25; 95% CI 0.87, 1.78; P = 0.218), breakthrough pain-free rate (66.7 vs. 61.9%; OR: 1.12; 95% CI 0.78, 1.59; P = 0.532) and pain score (1.97 ± 1.04 vs. 2.15 ± 1.24; P = 0.522).

Conclusions: Pharmacist-led management improved treatment adherence, quality of life, and the reporting of adverse events in opioid-tolerant patients with cancer pain.

Trial registration: ClinicalTrials.gov, NCT03455023.

Keywords: Adherence; Cancer pain; Opioid; Opioid tolerance; Pharmacist.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Eligibility, randomization, and analysis. Patients were randomly assigned to control group and intervention group; the control group received routine education and support, while the intervention group received additional individualized pharmacist-led care (one systematic evaluation and intervention during the period of hospitalization, one education on discharge day, and four telephone follow-up intervention after discharge). This figure shows the efficacy and safety populations as of the data cut-off date
Fig. 2
Fig. 2
Adherence score distribution of control group and intervention group (per-protocol analysis). The baseline data was shown above the X-axis, and the 30 days after discharge data was displayed under the X-axis; The green column indicates the proportion of patients in the intervention group and red column indicates control group. In the baseline, 63.9% of patients scored 4, 18.6% scored 3, 11.3% scored 2, 6.2% scored 1 in control group and 63.2% of patients scored 4, 25.3% scored 3, 6.9% scored 2, 4.6% scored 1 in intervention group; 30 days after discharge, 79.8% of patients scored 4, 11.9% scored 3, 4.8% scored 2, 3.6% scored 1 in control group and 93.3% of patients scored 4, 4.0% scored 3, 1.3% scored 2, 1.3% scored 1 in intervention group. Scored 4 indicated the good adherence, and the lower score indicated the worse adherence

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Source: PubMed

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