Individualized Pharmaceutical-care for Inpatients With Cancer Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03455023|
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain||Other: pharmaceutical care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Inpatients|
|Actual Study Start Date :||June 30, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Experimental: pharmaceutical care intervention group
Patients will receive individualized pharmaceutical care in addition to usual medical care.
Other: pharmaceutical care
Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.
No Intervention: control group
Patients will receive usual medical care.
- Change in medication adherence [ Time Frame: 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.
- Change in pain score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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] [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455023
|Contact: Ping Huang, Doctoremail@example.com|
|Zhejiang cancer hospital||Recruiting|
|Hangzhou, Zhejiang, China, 310022|
|Contact: Ping Huang, Doctor|
|Principal Investigator:||Ping Huang, Doctor||Zhejiang Cancer Hospital|