- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03439904
Individualized Pharmaceutical-care in Outpatients With Cancer Pain
January 13, 2019 updated by: Ping Huang, Zhejiang Cancer Hospital
Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Outpatients
The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant outpatients
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China, 310022
- Recruiting
- Zhejiang Cancer Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pharmaceutical care intervention group
Patients will receive individualized pharmaceutical care in addition to usual medical 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in medication adherence
Time Frame: 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.
|
Change from baseline at 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in pain score
Time Frame: 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 from baseline pain score at 1 month
|
Change in quality of life
Time Frame: 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 from baseline quality of life at 1 month
|
Change in patients' knowledge of cancer pain and analgesics
Time Frame: 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.
|
Change from baseline knowledge at 1 month
|
Incidence of adverse events [safety and tolerability]
Time Frame: 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.
|
Up to 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2018
Primary Completion (Anticipated)
June 30, 2019
Study Completion (Anticipated)
June 30, 2019
Study Registration Dates
First Submitted
February 14, 2018
First Submitted That Met QC Criteria
February 14, 2018
First Posted (Actual)
February 20, 2018
Study Record Updates
Last Update Posted (Actual)
January 15, 2019
Last Update Submitted That Met QC Criteria
January 13, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ECCOPG-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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