Back to resultsIndividualized Pharmaceutical-care in Outpatients With Cancer Pain
Primary Purpose
Cancer Pain
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pharmaceutical care
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Pain focused on measuring pharmaceutical care, adherence
Eligibility Criteria
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
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pharmaceutical care intervention group
control group
Arm Description
Patients will receive individualized pharmaceutical care in addition to usual medical care
Patients will receive usual medical care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 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 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.
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.
Full Information
NCT ID
NCT03439904
First Posted
February 14, 2018
Last Updated
January 13, 2019
Sponsor
Zhejiang Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03439904
Brief Title
Individualized Pharmaceutical-care in Outpatients With Cancer Pain
Official Title
Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Outpatients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
pharmaceutical care, adherence
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pharmaceutical care intervention group
Arm Type
Experimental
Arm Description
Patients will receive individualized pharmaceutical care in addition to usual medical care
Arm Title
control group
Arm Type
No Intervention
Arm Description
Patients will receive usual medical care
Intervention Type
Other
Intervention Name(s)
Pharmaceutical care
Intervention Description
Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.
Primary Outcome Measure Information:
Title
Change in medication adherence
Description
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.
Time Frame
Change from baseline at 1 month
Secondary Outcome Measure Information:
Title
Change in pain score
Description
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."
Time Frame
Change from baseline pain score at 1 month
Title
Change in quality of life
Description
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)
Time Frame
Change from baseline quality of life at 1 month
Title
Change in patients' knowledge of cancer pain and analgesics
Description
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.
Time Frame
Change from baseline knowledge at 1 month
Title
Incidence of adverse events [safety and tolerability]
Description
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.
Time Frame
Up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Huang
Phone
+86-571-88122118
Email
huangping1841@zjcc.org.cn
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Huang, Doctor
12. IPD Sharing Statement
Citations:
PubMed Identifier
36267757
Citation
Ding H, Song Y, Wu N, Zheng X, Wei Q, Sun Y, Xie R, Zhai Q, Xu S, Qi Y, Wang Y, Li H, Yang L, Fan Q, Zhao Q, Chen J, Shi J, Duan C, Du Q, Zhang Y, Song Z, Fu S, Cai Y, Huang X, Fang L, Liu Y, Huang P. Impact of individualized pharmaceutical care on efficacy and safety of opioid-tolerant outpatients with cancer pain: a multicenter randomized controlled trial. Ann Transl Med. 2022 Sep;10(18):989. doi: 10.21037/atm-22-4091.
Results Reference
derived
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Individualized Pharmaceutical-care in Outpatients With Cancer Pain
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