Individualized Pharmaceutical-care for Inpatients With Cancer Pain

This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients.

• pharmaceutical care (Other): Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.

Primary outcomes

• Change in medication adherence [Change from baseline at 1 month after discharge]: The investigators will measure the change in medication adherence via Morisky Scale. Morisky Scale contains 4 questions, and the total score ranges from 0 to 4 with lower scores indicating higher adherence.

Secondary outcomes

• Change in pain score [Change from baseline at 1 month after discharge]: Comparison of pain score of cancer pain patients with or without pharmaceutical care. Pain score will be assessed using numeric rating scale (NRS). An NRS allows a person to describe the intensity of his/her pain as a number usually ranging from 0 to 10, where "0" means "no pain" and "10" means pain as "bad as it could be."
• Change in quality of life [Change from baseline at 1 month after discharge]: Comparison of quality of life of cancer pain patients with or without pharmaceutical care. Quality of life is assessed using EuroQol- 5 Dimension (EQ-5D). It is a questionnaire to measure quality of life. It contains 5 domains: Mobility; Self-care; Usual activity; Pain; Anxiety/depression. It also contains a visual analogue scale. Weights are used to score the responses to the 5 domains, with scores ranging from 0 to 1 (where a score of 1 represents a perfect state). For the visual analogue scale, participants draw a line from a box to the point on the thermometer-like scale corresponding to their health state, 0-100 (100 = Best health state)
• Change in patients' knowledge of cancer pain and analgesics [Change from baseline at 1 month after discharge]: Comparison of knowledge of cancer pain and analgesics for cancer pain patients with or without pharmaceutical care. Knowledge of pain treatment and analgesics will be assessed using investigator designed questionnaire. This questionnaire consists of 16 items assessing patients' knowledge about cancer pain, treatment of cancer pain and medications for cancer pain. The total score ranges from 0 to 16 with higher score indicating better knowledge.
• Incidence of adverse events [safety and tolerability] [Up to 1 month after discharge]: Adverse events will be assessed throughout the study according the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Version 4.0. Number of subjects who experienced an adverse event in this study is presented.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients aged 18 years or older;
* Histologically confirmed solid tumor;
* Diagnosed chronic cancer pain;
* Opioid-tolerant patients;
* Overall survival is expected to be over 3 months;
* Karnofsky performance score≥50;
* Willing and able to comply with the protocol

Exclusion Criteria:

* Current pregnancy or breastfeeding;
* Patients diagnosed with non-cancer pain;
* Patients treated with patient-controlled analgesia;
* Patients with pathological fracture, gastrointestinal obstruction, severe infection, non-opioid related intractable constipation;
* Patients with mental disorder;
* Creatinine clearance rate <15mL/min;
* ALT or AST ≥ 10 fold of upper limit of normal value

• Results publication: Zheng X, Ding H, Xu S, Xie R, Liu Y, Zhai Q, Fang L, Tong Y, Sun J, Xin W, Wu N, Chen J, Shi W, Yang L, Li H, Shao J, Wang Y, Yu H, Zhang B, Du Q, Yang Y, Zhang X, Duan C, Zhao Q, Shi J, Huang J, Fan Q, Cheng H, Chen L, Kong S, Zhang H, Gong L, Zhang Y, Song Z, Yang Y, Zhou S, Huang C, Lin J, Wang C, Huang X, Wei Q, Sun Y, Huang P. Pharmacist-Led Management Improves Treatment Adherence and Quality of Life in Opioid-Tolerant Patients With Cancer Pain: A Randomized Controlled Trial. Pain Ther. 2022 Mar;11(1):241-252. doi: 10.1007/s40122-021-00342-0. Epub 2022 Jan 29. PMID 35092599

• Ping Huang, Doctor, Principal investigator, Zhejiang Cancer Hospital