Abbott Pharma

Individualized Pharmaceutical-care for Inpatients With Cancer Pain


Recruitment Status: Recruiting
Study Sponsor:
Zhejiang Cancer Hospital
Responsible Party:
Ping Huang

First Submitted Date: Jan 30, 2018
First Posted Date: Mar 06, 2018
Last Update Posted Date: Jan 15, 2019
Estimated Study Start Date: Jun 30, 2018
Estimated Primary Completion Date: Jun 30, 2019

Primary Outcome Measures: 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.

Secondary Outcome Measures: 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.

Other Outcome Measures: Not Provided
Descriptive Information
Brief Title: Individualized Pharmaceutical-care for Inpatients With Cancer Pain
Official Title: Impact of Individualized Pharmaceutical-care on Medication Adherence and Outcome of Cancer Pain in Opioid-tolerant Inpatients
Brief Summary: The purpose of the study is to investigate the impact of pharmaceutical care on cancer pain treatment for opioid-tolerant inpatients
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 inpatients.
Study Type: Interventional
Study Phase: N/A
Study Design: Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Not Provided

Study Masking: None (Open Label)

Study Masking Description: Not Provided

Study Primary Purpose: Supportive Care
Condition: Cancer Pain
Intervention: Other: pharmaceutical care
Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.
pharmaceutical care intervention group

Study Arms: Experimental: pharmaceutical care intervention group
Patients will receive individualized pharmaceutical care in addition to usual medical care.

No Intervention: control group
Patients will receive usual medical care.

Recruitment Information
Recruitment Status: Recruiting
Estimated Enrollment: 500
Estimated Study Completion Date: Jun 30, 2019
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: - Current pregnancy or breastfeeding; - Patients diagnosed with non-cancer pain; - Patients treated with patient-controlled analgesia; - Patients with pathological fracture, gastrointestinal obstruction, severe infection, non-opioid related intractable constipation; - Patients with mental disorder; - Creatinine clearance rate <15mL/min; - ALT or AST ? 10 fold of upper limit of normal value
Sex/Gender: All
Ages: 18 Years to N/A
Accepts Healthy Volunteers: No
Contacts: Name: Ping Huang, Doctor
Phone: +86-571-88122118
Email: huangping1841@zjcc.org.cn
Listed Location Country: China
NCT Number: NCT03455023
Has Data Monitoring Committee: Not Provided
U.S. FDA-regulated Product: Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.:
IPD Sharing Statement: Plan to Share IPD: Not Provided
Plan Description: Not Provided
Plan Time Frame: Not Provided
Plan Access Criteria: Not Provided
Responsible Party: Principal Investigator
Study Sponsor: Zhejiang Cancer Hospital
Collaborators: Not Provided
Investigators: Ping Huang, Doctor
PRS Account: Zhejiang Cancer Hospital
Verification Date: Jan 01, 2019