Individualized Pharmaceutical-care in Outpatients With Cancer Pain

Cancer Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03439904
• Other study ID #: ECCOPG-003
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2019
• Source: Zhejiang Cancer Hospital
• Contact: Ping Huang
• Phone: +86-571-88122118
• Email: huangping1841[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain

Intervention

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

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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