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The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients
This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pharmaceutical care intervention group | Experimental | Patients will receive individualized pharmaceutical care in addition to usual medical care. |
|
| control group | No Intervention | Patients will receive usual medical care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pharmaceutical care | Other | Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in medication adherence | 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. | Change from baseline at 1 month after discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain score | 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 from baseline at 1 month after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Huang, Doctor | Contact | +86-571-88122118 | huangping1841@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Ping Huang, Doctor | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang cancer hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35092599 | Derived | 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. |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| Change in quality of life | 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 from baseline at 1 month after discharge |
| Change in patients' knowledge of cancer pain and analgesics | 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. | Change from baseline at 1 month after discharge |
| Incidence of adverse events [safety and tolerability] | 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. | Up to 1 month after discharge |