Cancer Pain
Conditions
Keywords
pharmaceutical care, adherence
Brief summary
The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients
Detailed description
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.
Interventions
OTHERPharmaceutical care
Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in medication adherence | Change from baseline at 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score | Change from baseline pain score at 1 month | 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 quality of life at 1 month | 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 knowledge at 1 month | 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 | 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. |
Countries
China
Contacts
Primary ContactPing Huang
Outcome results
None listed