Individualized Pharmaceutical-care in Outpatients With Cancer Pain

Study Overview
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Brief Summary
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The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients

Detailed Description
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This study is a prospective multicenter randomized controlled study to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients treated with sustained released morphine, oxycodone, and transdermal fentanyl.

Official Title
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Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Outpatients

Conditions
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Cancer Pain

Intervention / Treatment
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* Other: Pharmaceutical care


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pharmaceutical care intervention group<br>Patients will receive individualized pharmaceutical care in addition to usual medical care | Other: Pharmaceutical care<br>* Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.<br>|
| No Intervention: control group<br>Patients will receive usual medical care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in medication adherence | The investigators will measure the change in medication adherence via Morisky Scale from baseline to 1 months. 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 pain score at 1 month | 
| 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 quality of life at 1 month | 
| 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 knowledge at 1 month | 
| 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 and percentage of subjects who experienced an adverse event in this study is presented. | Up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmaceutical care, adherence